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Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00925587
Recruitment Status : Completed
First Posted : June 22, 2009
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Anemia
Chronic Kidney Disease
Intervention Drug: darbepoetin alfa
Enrollment 358
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description Darbepoetin alfa Intravenous Once Every 2 Weeks Darbepoetin alfa Intravenous Once Monthly
Period Title: Overall Study
Started 178 180
Completed 142 155
Not Completed 36 25
Reason Not Completed
Protocol Specified Criteria             6             6
Physician Decision             4             1
Protocol Violation             6             4
Withdrawal by Subject             9             6
Death             5             5
Adverse Event             6             2
Lost to Follow-up             0             1
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM Total
Hide Arm/Group Description Darbepoetin alfa Intravenous Once Every 2 Weeks Darbepoetin alfa Intravenous Once Monthly Total of all reporting groups
Overall Number of Baseline Participants 175 180 355
Hide Baseline Analysis Population Description
Includes all subjects who received at least one dose of darbepoetin alfa on study. 3 subjects randomized to the Q2W arm failed to administer darbepoetin alfa
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 180 participants 355 participants
68.4  (14.1) 66.3  (15.2) 67.3  (14.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants 180 participants 355 participants
<65 years 60 67 127
>=65-<75 years 42 54 96
>=75 years 73 59 132
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 180 participants 355 participants
Female
107
  61.1%
104
  57.8%
211
  59.4%
Male
68
  38.9%
76
  42.2%
144
  40.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants 180 participants 355 participants
Black or African American 0 1 1
White or Caucasian 166 163 329
Other 9 16 25
Baseline Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 175 participants 180 participants 355 participants
9.13  (0.61) 9.11  (0.70) 9.12  (0.65)
1.Primary Outcome
Title Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
Hide Description The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.
Time Frame Baseline Week 33
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 154
Least Squares Mean (95% Confidence Interval)
Unit of Measure: g/dL
2.157
(1.984 to 2.330)
1.969
(1.803 to 2.135)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Darbepoetin Alfa Q2W, Darbepoetin Alfa QM
Comments Power = 90% at sample size calculation
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin -0.5 g/dL
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.188
Confidence Interval (2-Sided) 95%
-0.427 to 0.052
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.122
Estimation Comments Darbepoetin alfa QM - Darbepoetin alfa Q2W
2.Secondary Outcome
Title Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.
Hide Description [Not Specified]
Time Frame Baseline to Week 33
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 154
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
97.9
(95.5 to 100.0)
98.1
(95.9 to 100.0)
3.Secondary Outcome
Title Hb at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 154
Mean (Standard Error)
Unit of Measure: g/dL
9.17  (0.05) 9.12  (0.06)
4.Secondary Outcome
Title Hb at Week 3
Hide Description [Not Specified]
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 153
Mean (Standard Error)
Unit of Measure: g/dL
9.89  (0.08) 10.13  (0.10)
5.Secondary Outcome
Title Hb at Week 5
Hide Description [Not Specified]
Time Frame Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 152
Mean (Standard Error)
Unit of Measure: g/dL
10.58  (0.08) 10.28  (0.09)
6.Secondary Outcome
Title Hb at Week 7
Hide Description [Not Specified]
Time Frame Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 152
Mean (Standard Error)
Unit of Measure: g/dL
10.90  (0.09) 10.75  (0.10)
7.Secondary Outcome
Title Hb at Week 9
Hide Description [Not Specified]
Time Frame Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 153
Mean (Standard Error)
Unit of Measure: g/dL
11.24  (0.10) 10.79  (0.10)
8.Secondary Outcome
Title Hb at Week 11
Hide Description [Not Specified]
Time Frame Week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 151
Mean (Standard Error)
Unit of Measure: g/dL
11.35  (0.10) 11.17  (0.10)
9.Secondary Outcome
Title Hb at Week 13
Hide Description [Not Specified]
Time Frame Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 149
Mean (Standard Error)
Unit of Measure: g/dL
11.56  (0.10) 11.05  (0.10)
10.Secondary Outcome
Title Hb at Week 15
Hide Description [Not Specified]
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 150
Mean (Standard Error)
Unit of Measure: g/dL
11.42  (0.11) 11.25  (0.09)
11.Secondary Outcome
Title Hb at Week 17
Hide Description [Not Specified]
Time Frame Week 17
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 138 150
Mean (Standard Error)
Unit of Measure: g/dL
11.66  (0.10) 11.12  (0.09)
12.Secondary Outcome
Title Hb at Week 19
Hide Description [Not Specified]
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 148
Mean (Standard Error)
Unit of Measure: g/dL
11.50  (0.12) 11.20  (0.09)
13.Secondary Outcome
Title Hb at Week 21
Hide Description [Not Specified]
Time Frame Week 21
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 137 146
Mean (Standard Error)
Unit of Measure: g/dL
11.53  (0.10) 11.09  (0.08)
14.Secondary Outcome
Title Hb at Week 23
Hide Description [Not Specified]
Time Frame Week 23
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 138 148
Mean (Standard Error)
Unit of Measure: g/dL
11.36  (0.09) 11.08  (0.09)
15.Secondary Outcome
Title Hb at Week 25
Hide Description [Not Specified]
Time Frame Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 151
Mean (Standard Error)
Unit of Measure: g/dL
11.34  (0.10) 10.85  (0.09)
16.Secondary Outcome
Title Hb at Week 27
Hide Description [Not Specified]
Time Frame Week 27
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 138 150
Mean (Standard Error)
Unit of Measure: g/dL
11.22  (0.09) 11.07  (0.09)
17.Secondary Outcome
Title Hb at Week 29
Hide Description [Not Specified]
Time Frame Week 29
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 137 151
Mean (Standard Error)
Unit of Measure: g/dL
11.35  (0.10) 10.90  (0.09)
18.Secondary Outcome
Title Hb at Week 31
Hide Description [Not Specified]
Time Frame Week 31
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 152
Mean (Standard Error)
Unit of Measure: g/dL
11.31  (0.09) 11.28  (0.09)
19.Secondary Outcome
Title Hb at Week 33
Hide Description [Not Specified]
Time Frame Week 33
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 136 149
Mean (Standard Error)
Unit of Measure: g/dL
11.38  (0.10) 11.15  (0.10)
20.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 1
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
27.65
(26.59 to 28.76)
27.06
(26.09 to 28.06)
21.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 3
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
25.80
(24.64 to 27.00)
27.06
(26.09 to 28.06)
22.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 5
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
24.40
(22.70 to 26.23)
24.52
(22.70 to 26.50)
23.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 7
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
23.42
(21.42 to 25.61)
24.52
(22.70 to 26.50)
24.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 9
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
20.01
(17.36 to 23.07)
20.59
(17.89 to 23.70)
25.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 11
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
18.99
(16.22 to 22.24)
20.50
(17.83 to 23.58)
26.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 13
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 151
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
14.67
(11.97 to 17.98)
19.52
(16.79 to 22.69)
27.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 15
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
14.19
(11.52 to 17.47)
19.15
(16.42 to 22.33)
28.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 17
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 17
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
12.71
(10.15 to 15.92)
19.94
(17.28 to 23.02)
29.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 19
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
14.52
(11.97 to 17.61)
19.94
(17.28 to 23.01)
30.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 21
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 21
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 150
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
15.42
(12.96 to 18.36)
21.59
(19.20 to 24.29)
31.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 23
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 23
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
14.73
(12.35 to 17.57)
19.98
(17.39 to 22.94)
32.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 25
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
14.55
(12.16 to 17.41)
20.70
(18.10 to 23.68)
33.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 27
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 27
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
16.07
(13.69 to 18.85)
20.79
(18.18 to 23.77)
34.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 29
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 29
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 137 151
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
15.06
(12.75 to 17.78)
20.57
(17.74 to 23.85)
35.Secondary Outcome
Title Darbepoetin Alfa Dose at Week 31
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 31
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
14.48
(12.20 to 17.19)
19.39
(16.51 to 22.77)
36.Secondary Outcome
Title Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Weeks 29-33
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
15.21
(12.99 to 17.81)
19.68
(16.84 to 23.01)
37.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 3
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.931
(0.914 to 0.947)
1.000
(1.000 to 1.000)
38.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 5
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.882
(0.832 to 0.936)
0.907
(0.845 to 0.974)
39.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 7
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.845
(0.782 to 0.914)
0.907
(0.845 to 0.974)
40.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 9
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.724
(0.631 to 0.832)
0.761
(0.662 to 0.875)
41.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 11
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.684
(0.588 to 0.797)
0.758
(0.659 to 0.871)
42.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 13
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 151
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.531
(0.435 to 0.647)
0.719
(0.620 to 0.835)
43.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 15
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.512
(0.417 to 0.628)
0.707
(0.608 to 0.823)
44.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 17
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 17
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.459
(0.368 to 0.572)
0.737
(0.641 to 0.847)
45.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 19
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.525
(0.435 to 0.633)
0.737
(0.641 to 0.846)
46.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 21
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 21
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 150
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.556
(0.471 to 0.656)
0.797
(0.713 to 0.891)
47.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 23
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 23
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 141 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.533
(0.450 to 0.632)
0.738
(0.646 to 0.844)
48.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 25
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.526
(0.443 to 0.625)
0.764
(0.671 to 0.869)
49.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 27
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 27
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.581
(0.499 to 0.677)
0.768
(0.675 to 0.875)
50.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 29
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 29
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 137 151
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.544
(0.462 to 0.640)
0.762
(0.661 to 0.880)
51.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at Week 31
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Week 31
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.525
(0.443 to 0.622)
0.717
(0.613 to 0.839)
52.Secondary Outcome
Title Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Weeks 1-33
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 139 151
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/wk
25.95
(24.43 to 27.56)
29.65
(27.89 to 31.52)
53.Secondary Outcome
Title Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)
Hide Description [Not Specified]
Time Frame Weeks 1-33
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 142 154
Median (Inter-Quartile Range)
Unit of Measure: Weeks
5.0
(3.0 to 7.0)
5.0
(3.0 to 9.0)
54.Secondary Outcome
Title Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)
Hide Description Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame Evaluation Period
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description:
Darbepoetin alfa Intravenous Once Every 2 Weeks
Darbepoetin alfa Intravenous Once Monthly
Overall Number of Participants Analyzed 140 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.550
(0.471 to 0.643)
0.728
(0.625 to 0.849)
Time Frame 33 weeks
Adverse Event Reporting Description

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.

 
Arm/Group Title Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Hide Arm/Group Description Darbepoetin alfa Intravenous Once Every 2 Weeks Darbepoetin alfa Intravenous Once Monthly
All-Cause Mortality
Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Affected / at Risk (%) Affected / at Risk (%)
Total   52/175 (29.71%)   54/180 (30.00%) 
Blood and lymphatic system disorders     
Anaemia  1  2/175 (1.14%)  5/180 (2.78%) 
Lymphadenopathy  1  0/175 (0.00%)  1/180 (0.56%) 
Cardiac disorders     
Acute coronary syndrome  1  1/175 (0.57%)  0/180 (0.00%) 
Acute myocardial infarction  1  2/175 (1.14%)  0/180 (0.00%) 
Angina pectoris  1  1/175 (0.57%)  2/180 (1.11%) 
Arrhythmia  1  0/175 (0.00%)  1/180 (0.56%) 
Arrhythmia supraventricular  1  1/175 (0.57%)  0/180 (0.00%) 
Atrial fibrillation  1  2/175 (1.14%)  0/180 (0.00%) 
Atrial flutter  1  0/175 (0.00%)  1/180 (0.56%) 
Atrioventricular block complete  1  1/175 (0.57%)  1/180 (0.56%) 
Cardiac failure  1  6/175 (3.43%)  3/180 (1.67%) 
Cardiac failure acute  1  0/175 (0.00%)  1/180 (0.56%) 
Cardiac failure congestive  1  1/175 (0.57%)  1/180 (0.56%) 
Coronary artery disease  1  0/175 (0.00%)  1/180 (0.56%) 
Ischaemic cardiomyopathy  1  1/175 (0.57%)  0/180 (0.00%) 
Myocardial ischaemia  1  2/175 (1.14%)  0/180 (0.00%) 
Tachyarrhythmia  1  1/175 (0.57%)  0/180 (0.00%) 
Ventricular tachycardia  1  0/175 (0.00%)  1/180 (0.56%) 
Ear and labyrinth disorders     
Vertigo  1  1/175 (0.57%)  0/180 (0.00%) 
Eye disorders     
Cataract  1  0/175 (0.00%)  1/180 (0.56%) 
Retinal haemorrhage  1  0/175 (0.00%)  1/180 (0.56%) 
Visual impairment  1  2/175 (1.14%)  0/180 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/175 (0.57%)  0/180 (0.00%) 
Acute abdomen  1  0/175 (0.00%)  1/180 (0.56%) 
Alcoholic pancreatitis  1  0/175 (0.00%)  1/180 (0.56%) 
Diaphragmatic hernia  1  1/175 (0.57%)  0/180 (0.00%) 
Diarrhoea  1  0/175 (0.00%)  2/180 (1.11%) 
Dyspepsia  1  0/175 (0.00%)  2/180 (1.11%) 
Gastric ulcer haemorrhage  1  0/175 (0.00%)  1/180 (0.56%) 
Ileus  1  0/175 (0.00%)  3/180 (1.67%) 
Impaired gastric emptying  1  1/175 (0.57%)  0/180 (0.00%) 
Intestinal ischaemia  1  0/175 (0.00%)  1/180 (0.56%) 
Melaena  1  1/175 (0.57%)  0/180 (0.00%) 
General disorders     
Asthenia  1  0/175 (0.00%)  1/180 (0.56%) 
Chest pain  1  1/175 (0.57%)  1/180 (0.56%) 
Generalised oedema  1  1/175 (0.57%)  0/180 (0.00%) 
Inflammation  1  1/175 (0.57%)  0/180 (0.00%) 
Oedema peripheral  1  2/175 (1.14%)  1/180 (0.56%) 
Spinal pain  1  0/175 (0.00%)  1/180 (0.56%) 
Hepatobiliary disorders     
Biliary colic  1  1/175 (0.57%)  0/180 (0.00%) 
Cholecystitis  1  1/175 (0.57%)  0/180 (0.00%) 
Immune system disorders     
Anti-neutrophil cytoplasmic antibody positive vasculitis  1  0/175 (0.00%)  1/180 (0.56%) 
Infections and infestations     
Abdominal abscess  1  1/175 (0.57%)  0/180 (0.00%) 
Appendicitis  1  0/175 (0.00%)  1/180 (0.56%) 
Bronchitis  1  1/175 (0.57%)  1/180 (0.56%) 
Bronchopneumonia  1  0/175 (0.00%)  1/180 (0.56%) 
Erysipelas  1  0/175 (0.00%)  2/180 (1.11%) 
Gangrene  1  0/175 (0.00%)  1/180 (0.56%) 
Gastroenteritis  1  0/175 (0.00%)  1/180 (0.56%) 
Gastroenteritis viral  1  1/175 (0.57%)  0/180 (0.00%) 
Infection  1  0/175 (0.00%)  1/180 (0.56%) 
Lobar pneumonia  1  1/175 (0.57%)  0/180 (0.00%) 
Parainfluenzae virus infection  1  0/175 (0.00%)  1/180 (0.56%) 
Peritonitis  1  1/175 (0.57%)  0/180 (0.00%) 
Pneumonia  1  3/175 (1.71%)  1/180 (0.56%) 
Pyelonephritis chronic  1  1/175 (0.57%)  0/180 (0.00%) 
Sepsis  1  1/175 (0.57%)  0/180 (0.00%) 
Urinary tract infection  1  1/175 (0.57%)  2/180 (1.11%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/175 (0.00%)  1/180 (0.56%) 
Concussion  1  1/175 (0.57%)  0/180 (0.00%) 
Fall  1  0/175 (0.00%)  1/180 (0.56%) 
Femoral neck fracture  1  1/175 (0.57%)  0/180 (0.00%) 
Femur fracture  1  1/175 (0.57%)  1/180 (0.56%) 
Pelvic fracture  1  2/175 (1.14%)  0/180 (0.00%) 
Post procedural complication  1  0/175 (0.00%)  2/180 (1.11%) 
Radius fracture  1  1/175 (0.57%)  0/180 (0.00%) 
Skull fractured base  1  1/175 (0.57%)  0/180 (0.00%) 
Wrist fracture  1  1/175 (0.57%)  0/180 (0.00%) 
Investigations     
Blood glucose increased  1  0/175 (0.00%)  1/180 (0.56%) 
Blood potassium increased  1  1/175 (0.57%)  0/180 (0.00%) 
General physical condition abnormal  1  1/175 (0.57%)  0/180 (0.00%) 
International normalised ratio increased  1  1/175 (0.57%)  0/180 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/175 (0.00%)  1/180 (0.56%) 
Diabetes mellitus  1  3/175 (1.71%)  1/180 (0.56%) 
Diabetic ketoacidosis  1  0/175 (0.00%)  1/180 (0.56%) 
Electrolyte imbalance  1  0/175 (0.00%)  1/180 (0.56%) 
Fluid overload  1  0/175 (0.00%)  2/180 (1.11%) 
Hyperkalaemia  1  0/175 (0.00%)  2/180 (1.11%) 
Hypocalcaemia  1  0/175 (0.00%)  1/180 (0.56%) 
Hypoglycaemia  1  0/175 (0.00%)  2/180 (1.11%) 
Type 2 diabetes mellitus  1  1/175 (0.57%)  0/180 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/175 (0.00%)  1/180 (0.56%) 
Osteoarthritis  1  1/175 (0.57%)  1/180 (0.56%) 
Rhabdomyolysis  1  1/175 (0.57%)  0/180 (0.00%) 
Spinal osteoarthritis  1  1/175 (0.57%)  0/180 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  1/175 (0.57%)  0/180 (0.00%) 
Neoplasm malignant  1  1/175 (0.57%)  0/180 (0.00%) 
Oesophageal carcinoma  1  0/175 (0.00%)  1/180 (0.56%) 
Nervous system disorders     
Carotid artery stenosis  1  1/175 (0.57%)  0/180 (0.00%) 
Cerebral ischaemia  1  0/175 (0.00%)  1/180 (0.56%) 
Cerebrovascular accident  1  0/175 (0.00%)  1/180 (0.56%) 
Convulsion  1  1/175 (0.57%)  1/180 (0.56%) 
Hemiparesis  1  1/175 (0.57%)  0/180 (0.00%) 
Hypoaesthesia  1  1/175 (0.57%)  0/180 (0.00%) 
Ischaemic stroke  1  0/175 (0.00%)  1/180 (0.56%) 
Loss of consciousness  1  0/175 (0.00%)  2/180 (1.11%) 
Syncope  1  0/175 (0.00%)  2/180 (1.11%) 
Transient ischaemic attack  1  1/175 (0.57%)  0/180 (0.00%) 
Vascular encephalopathy  1  1/175 (0.57%)  0/180 (0.00%) 
Psychiatric disorders     
Depression  1  1/175 (0.57%)  0/180 (0.00%) 
Renal and urinary disorders     
Azotaemia  1  1/175 (0.57%)  0/180 (0.00%) 
Diabetic nephropathy  1  1/175 (0.57%)  1/180 (0.56%) 
Nephropathy  1  1/175 (0.57%)  1/180 (0.56%) 
Renal failure  1  4/175 (2.29%)  0/180 (0.00%) 
Renal failure acute  1  0/175 (0.00%)  4/180 (2.22%) 
Renal failure chronic  1  7/175 (4.00%)  4/180 (2.22%) 
Reproductive system and breast disorders     
Epididymitis  1  1/175 (0.57%)  0/180 (0.00%) 
Oedema genital  1  1/175 (0.57%)  0/180 (0.00%) 
Scrotal swelling  1  0/175 (0.00%)  1/180 (0.56%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis chronic  1  0/175 (0.00%)  1/180 (0.56%) 
Dyspnoea  1  2/175 (1.14%)  2/180 (1.11%) 
Epistaxis  1  0/175 (0.00%)  1/180 (0.56%) 
Pleural effusion  1  0/175 (0.00%)  1/180 (0.56%) 
Pneumonia aspiration  1  0/175 (0.00%)  1/180 (0.56%) 
Pulmonary oedema  1  1/175 (0.57%)  2/180 (1.11%) 
Skin and subcutaneous tissue disorders     
Dry gangrene  1  1/175 (0.57%)  0/180 (0.00%) 
Erythema  1  0/175 (0.00%)  1/180 (0.56%) 
Vascular disorders     
Aortic aneurysm  1  0/175 (0.00%)  1/180 (0.56%) 
Circulatory collapse  1  0/175 (0.00%)  1/180 (0.56%) 
Extremity necrosis  1  1/175 (0.57%)  0/180 (0.00%) 
Haematoma  1  1/175 (0.57%)  0/180 (0.00%) 
Hypertension  1  3/175 (1.71%)  2/180 (1.11%) 
Hypertensive crisis  1  0/175 (0.00%)  1/180 (0.56%) 
Orthostatic hypotension  1  0/175 (0.00%)  1/180 (0.56%) 
Peripheral ischaemia  1  0/175 (0.00%)  1/180 (0.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Darbepoetin Alfa Q2W Darbepoetin Alfa QM
Affected / at Risk (%) Affected / at Risk (%)
Total   68/175 (38.86%)   63/180 (35.00%) 
Gastrointestinal disorders     
Diarrhoea  1  10/175 (5.71%)  7/180 (3.89%) 
General disorders     
Asthenia  1  10/175 (5.71%)  5/180 (2.78%) 
Oedema peripheral  1  17/175 (9.71%)  14/180 (7.78%) 
Infections and infestations     
Urinary tract infection  1  8/175 (4.57%)  10/180 (5.56%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  7/175 (4.00%)  12/180 (6.67%) 
Vascular disorders     
Hypertension  1  36/175 (20.57%)  30/180 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00925587     History of Changes
Other Study ID Numbers: 20060163
2006-003173-27 ( EudraCT Number )
First Submitted: May 28, 2009
First Posted: June 22, 2009
Results First Submitted: December 5, 2013
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014