Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00737711
Recruitment Status : Completed
First Posted : August 19, 2008
Results First Posted : June 2, 2016
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia
Intervention Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Enrollment 189
Recruitment Details The study was conducted from 08 July 2008 to 31 May 2009 across 16 centers in India. A total of 189 participants were enrolled in the study.
Pre-assignment Details  
Arm/Group Title MIRCERA
Hide Arm/Group Description Participants with chronic renal anemia, on dialysis, received 0.6 microgram per kilogram of body weight (mcg/kg) of Methoxy polyethylene glycol-epoetin beta (MIRCERA/RO0503821), intravenously once every two weeks for 16 weeks. A telephonic / physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Period Title: Overall Study
Started 189
Completed 158
Not Completed 31
Reason Not Completed
Adverse Event             2
Death             8
Failure to return             4
Protocol Violation             1
Withdrawal by Subject             5
Blood transfusion             6
Other             5
Arm/Group Title MIRCERA
Hide Arm/Group Description Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Baseline Participants 189
Hide Baseline Analysis Population Description
Safety population included all participants who receive at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 189 participants
49.74  (14.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants
Female
50
  26.5%
Male
139
  73.5%
1.Primary Outcome
Title Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
Hide Description The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.
Time Frame Baseline (Week 0) and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 159
Mean (Standard Deviation)
Unit of Measure: gram/deciliter (g/dL)
2.11  (1.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIRCERA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Paired t-test was used to estimation of p-value.
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter
Hide Description Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 144
Mean (Standard Deviation)
Unit of Measure: Weeks
6.10  (3.87)
3.Secondary Outcome
Title Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
Hide Description The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.
Time Frame Week 12 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: Weeks
3.07  (1.00)
4.Secondary Outcome
Title Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
Hide Description The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.
Time Frame Week 12 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of the study drug.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.20
(38.56 to 53.97)
5.Secondary Outcome
Title Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Hide Description An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above
Time Frame Up to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: Participants
Participants with any AE 53
Participants with SAE 24
Deaths 8
6.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiogram
Hide Description Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: Participants
Participants with abnormal ECG, Week 0, n=189 52
Participants with abnormal ECG, Week 16, n=164 49
7.Secondary Outcome
Title Number of Participants With Reports of Blood Transfusions
Hide Description Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who receive at least one dose of study drug. Participants available at the time of assessment were included.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: Participants
White blood cells transfusions 1
Pack cell transfusions 6
Pure red cell transfusions 0
8.Secondary Outcome
Title Number of Participants With Reports of Anti-Epoetin Antibodies
Hide Description Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who receive at least one dose of study drug.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: Participants
0
9.Secondary Outcome
Title Mean White Blood Cell Count Over Time
Hide Description The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 187
Mean (Standard Deviation)
Unit of Measure: cells per cubic millimeter
Week 0, n = 187 9382.89  (11644.69)
Week 4, n = 173 9181.27  (12689.96)
Week 10, n = 167 9361.38  (13319.73)
Week 16, n = 159 9023.71  (13109.61)
10.Secondary Outcome
Title Mean Value of Mean Corpuscular Volume Over Time
Hide Description Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 183
Mean (Standard Deviation)
Unit of Measure: Femtoliter
Week 0, n = 183 87.05  (11.37)
Week 4, n = 169 89.17  (6.99)
Week 10, n = 167 88.46  (6.85)
Week 16, n = 159 88.03  (9.36)
11.Secondary Outcome
Title Mean Hypochromic Red Blood Cells Over Time
Hide Description Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: cells per cubic millimeter
Week 0, n = 39 3.84  (5.78)
Week 4, n = 39 2.74  (1.13)
Week 10, n = 36 3.23  (1.27)
Week 16, n = 31 3.52  (1.50)
12.Secondary Outcome
Title Mean Platelet Count Over Time
Hide Description Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 186
Mean (Standard Deviation)
Unit of Measure: cells per cubic millimeter
Week 0, n = 186 214629.03  (77442.90)
Week 4, n = 177 203050.85  (81720.79)
Week 10, n = 167 204922.16  (78064.46)
Week 16, n = 158 194550.63  (78937.74)
13.Secondary Outcome
Title Mean Serum Iron Over Time
Hide Description Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 187
Mean (Standard Deviation)
Unit of Measure: microgram/deciliter (mcg/dL)
Week 0, n = 187 91.72  (53.44)
Week 4, n = 171 80.17  (39.45)
Week 10, n = 166 87.62  (42.90)
Week 16, n = 157 91.70  (47.36)
14.Secondary Outcome
Title Mean Serum Ferritin Over Time
Hide Description Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 188
Mean (Standard Deviation)
Unit of Measure: nanogram /milliliter (ng/mL)
Week 0, n = 188 963.28  (2398.89)
Week 4, n = 170 702.37  (679.50)
Week 10, n = 161 686.42  (723.22)
Week 16, n = 153 641.26  (627.66)
15.Secondary Outcome
Title Mean Transferrin Over Time
Hide Description Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Week 0, n = 73 173.48  (108.93)
Week 4, n = 66 176.97  (105.16)
Week 10, n = 55 237.98  (304.97)
Week 16, n = 58 181.50  (174.83)
16.Secondary Outcome
Title Mean Total Iron-binding Capacity Over Time
Hide Description Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 185
Mean (Standard Deviation)
Unit of Measure: mcg/dL
Week 0, n = 185 247.06  (64.08)
Week 4, n = 166 243.25  (71.20)
Week 10, n = 160 245.30  (69.25)
Week 16, n = 153 245.30  (70.03)
17.Secondary Outcome
Title Mean Transferrin Saturation Over Time
Hide Description Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 186
Mean (Standard Deviation)
Unit of Measure: Percentage of transferrin saturation
Week 0, n = 186 40.39  (27.87)
Week 4, n=168 35.31  (22.46)
Week 10, n=161 36.91  (18.85)
Week 16, n = 153 38.31  (21.27)
18.Secondary Outcome
Title Mean Serum Albumin Over Time
Hide Description Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 185
Mean (Standard Deviation)
Unit of Measure: g/dL
Week 0, n = 185 3.51  (0.54)
Week 4, n = 172 3.48  (0.53)
Week 10, n = 167 3.57  (0.57)
Week 16, n = 155 3.61  (0.54)
19.Secondary Outcome
Title Mean Serum Globulin Over Time
Hide Description Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 179
Mean (Standard Deviation)
Unit of Measure: g/dL
Week 0, n = 179 3.36  (0.67)
Week 4, n = 163 3.24  (0.63)
Week 10, n = 159 3.33  (0.63)
Week 16, n = 150 3.50  (2.50)
20.Secondary Outcome
Title Mean Serum Creatinine Over Time
Hide Description Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 186
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0, n = 186 8.25  (3.05)
Week 4, n = 171 8.65  (3.09)
Week 10, n = 168 9.48  (7.69)
Week 16, n = 158 9.05  (3.31)
21.Secondary Outcome
Title Mean Blood Urea Nitrogen Over Time
Hide Description Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0, n = 181 68.98  (48.61)
Week 4, n = 170 66.19  (42.13)
Week 10, n = 168 67.21  (42.29)
Week 16, n = 157 69.88  (47.77)
22.Secondary Outcome
Title Mean Serum Potassium Over Time
Hide Description Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 183
Mean (Standard Deviation)
Unit of Measure: millimoles per liter (mmol/L)
Week 0, n = 183 5.76  (9.28)
Week 4, n = 168 5.23  (0.97)
Week 10, n = 168 7.53  (16.82)
Week 16, n = 157 8.30  (37.90)
23.Secondary Outcome
Title Mean Serum Sodium Over Time
Hide Description Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 0, n = 184 136.4  (10.67)
Week 4, n = 168 136.3  (11.32)
Week 10, n = 168 133.9  (20.98)
Week 16, n = 156 137.0  (11.19)
24.Secondary Outcome
Title Mean Serum Phosphate Over Time
Hide Description Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 166
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0, n = 166 6.20  (7.50)
Week 4, n = 156 6.32  (7.58)
Week 10, n = 155 8.71  (34.13)
Week 16, n = 146 6.17  (2.16)
25.Secondary Outcome
Title Mean Serum Bilirubin Over Time
Hide Description Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0, n = 142 0.58  (0.32)
Week 4, n = 124 0.68  (0.86)
Week 10, n = 123 0.70  (1.08)
Week 16, n = 117 0.62  (0.50)
26.Secondary Outcome
Title Mean Aspartate Transaminase Over Time
Hide Description Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: Units/Liter (U/L)
Week 0, n = 184 22.33  (13.06)
Week 4, n = 171 21.69  (14.93)
Week 10, n = 166 24.61  (19.44)
Week 16, n = 157 22.63  (18.53)
27.Secondary Outcome
Title Mean Alanine Aminotransferase Over Time
Hide Description Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 185
Mean (Standard Deviation)
Unit of Measure: U/L
Week 0, n = 185 27.89  (19.38)
Week 4, n = 171 26.80  (21.57)
Week 10, n = 166 28.11  (25.02)
Week 16, n = 157 29.21  (24.45)
28.Secondary Outcome
Title Mean Serum Alkaline Phosphatase Over Time
Hide Description Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time Frame Baseline (Week 0), Week 4, Week 10, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Arm/Group Title MIRCERA
Hide Arm/Group Description:
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
Overall Number of Participants Analyzed 175
Mean (Standard Deviation)
Unit of Measure: U/L
Week 0, n = 175 176.2  (208.4)
Week 4, n = 159 161.7  (197.8)
Week 10, n = 156 161.7  (172.7)
Week 16, n = 145 153.5  (135.2)
Time Frame Up to Week 18
Adverse Event Reporting Description Safety population included all participants who receive at least one dose of study drug.
 
Arm/Group Title MIRCERA
Hide Arm/Group Description Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
All-Cause Mortality
MIRCERA
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
MIRCERA
Affected / at Risk (%)
Total   24/189 (12.70%) 
Cardiac disorders   
Cardio-respiratory arrest  1  4/189 (2.12%) 
Pericardial effusion  1  1/189 (0.53%) 
Gastrointestinal disorders   
Haematemesis  1  1/189 (0.53%) 
Haemorrhoids  1  1/189 (0.53%) 
General disorders   
Death  1  3/189 (1.59%) 
Pyrexia  1  4/189 (2.12%) 
Infections and infestations   
Cellulitis  1  1/189 (0.53%) 
Lower respiratory tract infection  1  2/189 (1.06%) 
Pneumonia  1  2/189 (1.06%) 
Sepsis  1  1/189 (0.53%) 
Metabolism and nutrition disorders   
Diabetic foot  1  1/189 (0.53%) 
Hyperkalaemia  1  1/189 (0.53%) 
Musculoskeletal and connective tissue disorders   
Myositis  1  1/189 (0.53%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema  1  2/189 (1.06%) 
Surgical and medical procedures   
Amputation  1  1/189 (0.53%) 
Arteriovenous fistula operation  1  2/189 (1.06%) 
Vascular disorders   
Accelerated hypertension  1  1/189 (0.53%) 
Hypotension  1  2/189 (1.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MIRCERA
Affected / at Risk (%)
Total   11/189 (5.82%) 
General disorders   
Pyrexia  1  11/189 (5.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00737711    
Other Study ID Numbers: ML21822
First Submitted: August 18, 2008
First Posted: August 19, 2008
Results First Submitted: March 8, 2016
Results First Posted: June 2, 2016
Last Update Posted: June 2, 2016