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A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT00394953
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia
Interventions Drug: Darbepoetin alfa
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Enrollment 490
Recruitment Details The study was conducted from 20 December 2006 to 27 November 2008 in Europe along with Canada and Australia. A total of 490 eligible participants were enrolled.
Pre-assignment Details Out of 490 participants, one did not receive the study drug and was excluded from the safety population.
Arm/Group Title MIRCERA Darbepoetin Alfa
Hide Arm/Group Description Participants with anemia in chronic kidney disease (CKD) who were on hemodialysis received methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) intravenously (IV) once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 microgram per month (mcg/month) for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively. Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 to Week 52.
Period Title: First Treatment Period
Started 245 244
Completed 216 222
Not Completed 29 22
Reason Not Completed
Adverse Event             1             2
Death             6             7
Lack of Efficacy             1             1
Withdrawal by Subject             6             3
Lost to Follow-up             0             1
Renal transplant             11             7
Not defined             4             1
Period Title: Second Treatment Period
Started 216 222
Completed 187 148
Not Completed 29 74
Reason Not Completed
Adverse Event             2             5
Death             8             4
Lack of Efficacy             9             47
Withdrawal by Subject             3             3
Lost to Follow-up             0             1
Renal transplant             4             6
Not defined             3             8
Arm/Group Title MIRCERA Darbepoetin Alfa Total
Hide Arm/Group Description Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively. Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52. Total of all reporting groups
Overall Number of Baseline Participants 245 244 489
Hide Baseline Analysis Population Description
The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 245 participants 244 participants 489 participants
66.2  (13.64) 65.4  (13.91) 65.8  (13.77)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 244 participants 489 participants
Female
97
  39.6%
89
  36.5%
186
  38.0%
Male
148
  60.4%
155
  63.5%
303
  62.0%
1.Primary Outcome
Title Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period
Hide Description Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb >= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.
Time Frame Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title MIRCERA Darbepoetin Alfa
Hide Arm/Group Description:
Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Overall Number of Participants Analyzed 245 245
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
64.1
(57.7 to 70.1)
40.4
(34.2 to 46.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIRCERA, Darbepoetin Alfa
Comments The proportion of responders treated with methoxy polyethylene glycol-epoetin beta versus the proportion of responders treated with darbepoetin alpha during the evaluation period.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.63
Confidence Interval (2-Sided) 95%
1.83 to 3.79
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time
Hide Description All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.
Time Frame Week 27 to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Data is presented for the participants available at the time of assessment.
Arm/Group Title MIRCERA Darbepoetin Alfa
Hide Arm/Group Description:
Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Overall Number of Participants Analyzed 211 219
Mean (Standard Deviation)
Unit of Measure: percent change
6.8  (51.0) 58.8  (76.5)
3.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormality Over Time
Hide Description Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.
Time Frame Up to Week 53
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.
Arm/Group Title MIRCERA Darbepoetin Alfa
Hide Arm/Group Description:
Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Overall Number of Participants Analyzed 242 243
Measure Type: Number
Unit of Measure: participants
Platelets-H, n = 241, 243 1 5
Platelets-L, n = 241, 243 18 5
WBC-H, n = 242, 243 4 7
WBC-L, n = 242, 243 10 4
ALT-H, n = 241, 242 7 5
ALP-H, n = 240, 242 12 14
AST-H, n = 239, 240 4 6
Albumin-L, n = 240, 242 22 27
Phosphate-H, n = 240, 242 87 92
Phosphate-L, n = 240, 242 36 25
Potassium-H, n = 240, 242 54 41
Potassium-L, n = 240, 242 2 5
4.Secondary Outcome
Title Median Blood Pressure Over Time
Hide Description Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.
Time Frame Baseline (Week -4 to Week -1), Week 28, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.
Arm/Group Title MIRCERA Darbepoetin Alfa
Hide Arm/Group Description:
Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Overall Number of Participants Analyzed 245 244
Median (Full Range)
Unit of Measure: millimeter of mercury
PrD DBP, Baseline, n = 245, 244
75
(32 to 139)
70
(34 to 206)
PrD DBP, Week 28, n = 211, 219
73
(42 to 118)
71
(39 to 107)
PrD DBP, Week 52, n = 187, 147
70
(21 to 107)
70
(39 to 101)
PoD DBP, Baseline, n = 245, 244
70
(33 to 113)
70
(30 to 132)
PoD DBP, Week 28, n = 213, 218
70
(26 to 101)
70
(30 to 127)
PoD DBP, Week 52, n = 186, 148
70
(18 to 107)
65
(33 to 107)
PrD SBP, Baseline, n = 245, 244
140
(83 to 206)
140
(75 to 241)
PrD SBP, Week 28, n = 211, 219
140
(89 to 219)
140
(62 to 199)
PrD SBP, Week 52, n = 187, 147
140
(85 to 195)
132
(84 to 195)
PoD SBP, Baseline, n = 245, 244
133
(83 to 215)
130
(61 to 248)
PoD SBP, Week 28, n = 213, 220
134
(73 to 228)
137
(71 to 200)
PoD SBP, Week 52, n = 186, 148
139
(90 to 204)
127
(70 to 198)
5.Secondary Outcome
Title Mean Pulse Rate Over Time
Hide Description Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.
Time Frame Baseline (Week -4 to Week -1), Week 28, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.
Arm/Group Title MIRCERA Darbepoetin Alfa
Hide Arm/Group Description:
Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Overall Number of Participants Analyzed 245 244
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline, n = 245, 244 73  (11.1) 73  (12.3)
Week 28, n = 211, 215 74  (13.0) 72  (12.6)
Week 52, n = 184, 147 73  (12.5) 71  (11.3)
6.Secondary Outcome
Title Number of Participants With Any 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 adverse event that can result in death or is life-threatening or required in participants 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. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.
Time Frame From screening to Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Among the 14 deaths in Darbepoetin alfa group, 3 participants died after withdrawal from the study and within 30 days after last dose of study drug.
Arm/Group Title MIRCERA Darbepoetin Alfa
Hide Arm/Group Description:
Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Overall Number of Participants Analyzed 245 244
Measure Type: Number
Unit of Measure: Participants
Participants with any AE 222 217
Participants with any SAE 99 94
Deaths 14 14
Time Frame Up to Week 56
Adverse Event Reporting Description The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
 
Arm/Group Title MIRCERA Darbepoetin Alfa
Hide Arm/Group Description Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively. Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
All-Cause Mortality
MIRCERA Darbepoetin Alfa
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MIRCERA Darbepoetin Alfa
Affected / at Risk (%) Affected / at Risk (%)
Total   99/245 (40.41%)   94/244 (38.52%) 
Cardiac disorders     
Myocardial infarction  1  4/245 (1.63%)  3/244 (1.23%) 
Acute coronary syndrome  1  2/245 (0.82%)  3/244 (1.23%) 
Atrial fibrillation  1  3/245 (1.22%)  2/244 (0.82%) 
Angina pectoris  1  2/245 (0.82%)  2/244 (0.82%) 
Angina unstable  1  2/245 (0.82%)  2/244 (0.82%) 
Cardiac failure congestive  1  1/245 (0.41%)  1/244 (0.41%) 
Acute myocardial infarction  1  0/245 (0.00%)  1/244 (0.41%) 
Aortic valve stenosis  1  1/245 (0.41%)  0/244 (0.00%) 
Arteriosclerosis coronary artery  1  0/245 (0.00%)  1/244 (0.41%) 
Atrioventricular block second degree  1  1/245 (0.41%)  0/244 (0.00%) 
Coronary artery disease  1  1/245 (0.41%)  0/244 (0.00%) 
Coronary artery insufficiency  1  1/245 (0.41%)  0/244 (0.00%) 
Electromechanical dissociation  1  0/245 (0.00%)  1/244 (0.41%) 
Ischaemic cardiomyopathy  1  0/245 (0.00%)  1/244 (0.41%) 
Mitral valve stenosis  1  0/245 (0.00%)  1/244 (0.41%) 
Myocardial ischaemia  1  1/245 (0.41%)  0/244 (0.00%) 
Postinfarction angina  1  1/245 (0.41%)  0/244 (0.00%) 
Supraventricular tachycardia  1  0/245 (0.00%)  1/244 (0.41%) 
Congenital, familial and genetic disorders     
Congenital cystic kidney disease  1  0/245 (0.00%)  2/244 (0.82%) 
Adenomatous polyposis coli  1  1/245 (0.41%)  0/244 (0.00%) 
Ear and labyrinth disorders     
Sudden hearing loss  1  0/245 (0.00%)  1/244 (0.41%) 
Vertigo  1  1/245 (0.41%)  0/244 (0.00%) 
Endocrine disorders     
Goitre  1  1/245 (0.41%)  0/244 (0.00%) 
Hyperparathyroidism Secondary  1  1/245 (0.41%)  0/244 (0.00%) 
Hypothyroidism  1  1/245 (0.41%)  0/244 (0.00%) 
Eye disorders     
Cataract  1  2/245 (0.82%)  1/244 (0.41%) 
Gastrointestinal disorders     
Inguinal hernia  1  1/245 (0.41%)  2/244 (0.82%) 
Intestinal ischaemia  1  1/245 (0.41%)  2/244 (0.82%) 
Rectal haemorrhage  1  0/245 (0.00%)  2/244 (0.82%) 
Acute abdomen  1  1/245 (0.41%)  0/244 (0.00%) 
Colitis ulcerative  1  1/245 (0.41%)  0/244 (0.00%) 
Colonic polyp  1  1/245 (0.41%)  0/244 (0.00%) 
Diarrhoea  1  1/245 (0.41%)  0/244 (0.00%) 
Diverticulum intestinal haemorrhagic  1  1/245 (0.41%)  0/244 (0.00%) 
Enteritis  1  0/245 (0.00%)  1/244 (0.41%) 
Erosive oesophagitis  1  1/245 (0.41%)  0/244 (0.00%) 
Faecalith  1  1/245 (0.41%)  0/244 (0.00%) 
Gastritis haemorrhagic  1  0/245 (0.00%)  1/244 (0.41%) 
Gastrointestinal haemorrhage  1  1/245 (0.41%)  0/244 (0.00%) 
Gastrointestinal telangiectasia  1  0/245 (0.00%)  1/244 (0.41%) 
Gastrointestinal ulcer haemorrhage  1  0/245 (0.00%)  1/244 (0.41%) 
Haematemesis  1  0/245 (0.00%)  1/244 (0.41%) 
Haemorrhoidal haemorrhage  1  0/245 (0.00%)  1/244 (0.41%) 
Hiatus Hernia  1  1/245 (0.41%)  0/244 (0.00%) 
Large intestinal ulcer haemorrhage  1  0/245 (0.00%)  1/244 (0.41%) 
Pancreatitis  1  0/245 (0.00%)  1/244 (0.41%) 
Peptic ulcer haemorrhage  1  0/245 (0.00%)  1/244 (0.41%) 
Subileus  1  1/245 (0.41%)  0/244 (0.00%) 
Umbilical hernia  1  0/245 (0.00%)  1/244 (0.41%) 
Vomiting  1  0/245 (0.00%)  1/244 (0.41%) 
General disorders     
Catheter thrombosis  1  0/245 (0.00%)  1/244 (0.41%) 
General physical health deterioration  1  0/245 (0.00%)  1/244 (0.41%) 
Multi-Organ failure  1  0/245 (0.00%)  1/244 (0.41%) 
Non-cardiac chest pain  1  1/245 (0.41%)  0/244 (0.00%) 
Pyrexia  1  0/245 (0.00%)  1/244 (0.41%) 
Sudden cardiac death  1  1/245 (0.41%)  0/244 (0.00%) 
Sudden death  1  1/245 (0.41%)  0/244 (0.00%) 
Hepatobiliary disorders     
Acute hepatic failure  1  1/245 (0.41%)  0/244 (0.00%) 
Cholangitis  1  0/245 (0.00%)  1/244 (0.41%) 
Cholecystitis  1  1/245 (0.41%)  0/244 (0.00%) 
Cholecystitis acute  1  1/245 (0.41%)  0/244 (0.00%) 
Immune system disorders     
Amyloidosis  1  0/245 (0.00%)  1/244 (0.41%) 
Infections and infestations     
Sepsis  1  3/245 (1.22%)  5/244 (2.05%) 
Pneumonia  1  3/245 (1.22%)  4/244 (1.64%) 
Bronchitis  1  3/245 (1.22%)  1/244 (0.41%) 
Gastroenteritis  1  2/245 (0.82%)  2/244 (0.82%) 
Catheter related infection  1  1/245 (0.41%)  2/244 (0.82%) 
Catheter sepsis  1  3/245 (1.22%)  0/244 (0.00%) 
Septic shock  1  2/245 (0.82%)  1/244 (0.41%) 
Diverticulitis  1  1/245 (0.41%)  1/244 (0.41%) 
Erysipelas  1  2/245 (0.82%)  0/244 (0.00%) 
Staphylococcal infection  1  1/245 (0.41%)  1/244 (0.41%) 
Staphylococcal sepsis  1  2/245 (0.82%)  0/244 (0.00%) 
Urinary tract infection  1  0/245 (0.00%)  2/244 (0.82%) 
Abscess limb  1  0/245 (0.00%)  1/244 (0.41%) 
Arteriovenous graft site infection  1  0/245 (0.00%)  1/244 (0.41%) 
Arthritis bacterial  1  1/245 (0.41%)  0/244 (0.00%) 
Bronchopneumonia  1  0/245 (0.00%)  1/244 (0.41%) 
Cellulitis  1  0/245 (0.00%)  1/244 (0.41%) 
Central line infection  1  1/245 (0.41%)  0/244 (0.00%) 
Clostridium difficile colitis  1  0/245 (0.00%)  1/244 (0.41%) 
Implant site abscess  1  1/245 (0.41%)  0/244 (0.00%) 
Lower respiratory tract infection  1  1/245 (0.41%)  0/244 (0.00%) 
Pharyngitis  1  0/245 (0.00%)  1/244 (0.41%) 
Post procedural sepsis  1  1/245 (0.41%)  0/244 (0.00%) 
Post operative wound infection  1  0/245 (0.00%)  1/244 (0.41%) 
Pyelonephritis  1  0/245 (0.00%)  1/244 (0.41%) 
Pyelonephritis acute  1  0/245 (0.00%)  1/244 (0.41%) 
Pyelonephritis chronic  1  0/245 (0.00%)  1/244 (0.41%) 
Respiratory tract infection  1  0/245 (0.00%)  1/244 (0.41%) 
Staphylococcal bacteraemia  1  1/245 (0.41%)  0/244 (0.00%) 
Streptococcal infection  1  1/245 (0.41%)  0/244 (0.00%) 
Tracheitis  1  1/245 (0.41%)  0/244 (0.00%) 
Upper respiratory tract infection  1  1/245 (0.41%)  0/244 (0.00%) 
Urosepsis  1  1/245 (0.41%)  0/244 (0.00%) 
Wound infection  1  1/245 (0.41%)  0/244 (0.00%) 
Injury, poisoning and procedural complications     
Arteriovenous Fistula site complication  1  8/245 (3.27%)  5/244 (2.05%) 
Arteriovenous fistula thrombosis  1  10/245 (4.08%)  2/244 (0.82%) 
Arteriovenous graft thrombosis  1  1/245 (0.41%)  4/244 (1.64%) 
Arteriovenous fistula aneurysm  1  1/245 (0.41%)  2/244 (0.82%) 
Vascular graft complication  1  1/245 (0.41%)  2/244 (0.82%) 
Arteriovenous graft site haemorrhage  1  1/245 (0.41%)  1/244 (0.41%) 
Femoral neck fracture  1  1/245 (0.41%)  1/244 (0.41%) 
Femur fracture  1  1/245 (0.41%)  1/244 (0.41%) 
Procedural Hypotension  1  1/245 (0.41%)  1/244 (0.41%) 
Anastomotic haemorrhage  1  1/245 (0.41%)  0/244 (0.00%) 
Arteriovenous fistula site haematoma  1  1/245 (0.41%)  0/244 (0.00%) 
Head injury  1  1/245 (0.41%)  0/244 (0.00%) 
Hip fracture  1  0/245 (0.00%)  1/244 (0.41%) 
Medical device complication  1  1/245 (0.41%)  0/244 (0.00%) 
Operative haemorrhage  1  0/245 (0.00%)  1/244 (0.41%) 
Overdose  1  1/245 (0.41%)  0/244 (0.00%) 
Radius fracture  1  1/245 (0.41%)  0/244 (0.00%) 
Stent occlusion  1  0/245 (0.00%)  1/244 (0.41%) 
Traumatic haematoma  1  0/245 (0.00%)  1/244 (0.41%) 
Investigations     
C-reactive protein increased  1  0/245 (0.00%)  1/244 (0.41%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  4/245 (1.63%)  1/244 (0.41%) 
Fluid overload  1  3/245 (1.22%)  1/244 (0.41%) 
Anorexia  1  0/245 (0.00%)  1/244 (0.41%) 
Cachexia  1  0/245 (0.00%)  1/244 (0.41%) 
Diabetic foot  1  0/245 (0.00%)  1/244 (0.41%) 
Diabetic ketoacidosis  1  1/245 (0.41%)  0/244 (0.00%) 
Hyperglycaemia  1  1/245 (0.41%)  0/244 (0.00%) 
Hypervolaemia  1  1/245 (0.41%)  0/244 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/245 (0.41%)  1/244 (0.41%) 
Arthritis  1  0/245 (0.00%)  1/244 (0.41%) 
Exostosis  1  0/245 (0.00%)  1/244 (0.41%) 
Osteonecrosis  1  0/245 (0.00%)  1/244 (0.41%) 
Spinal osteoarthritis  1  1/245 (0.41%)  0/244 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile duct cancer  1  0/245 (0.00%)  1/244 (0.41%) 
Bladder Cancer  1  1/245 (0.41%)  0/244 (0.00%) 
Breast cancer  1  1/245 (0.41%)  0/244 (0.00%) 
Colon cancer  1  1/245 (0.41%)  0/244 (0.00%) 
Colon neoplasm  1  0/245 (0.00%)  1/244 (0.41%) 
Desmoid tumour  1  0/245 (0.00%)  1/244 (0.41%) 
Endometrial cancer  1  1/245 (0.41%)  0/244 (0.00%) 
Meigs’ syndrome  1  0/245 (0.00%)  1/244 (0.41%) 
Multiple myeloma  1  0/245 (0.00%)  1/244 (0.41%) 
Neurilemmoma malignant  1  1/245 (0.41%)  0/244 (0.00%) 
Pancreatic carcinoma  1  1/245 (0.41%)  0/244 (0.00%) 
Prostate cancer  1  1/245 (0.41%)  0/244 (0.00%) 
Small cell lung cancer stage unspecified  1  1/245 (0.41%)  0/244 (0.00%) 
Squamous cell carcinoma of skin  1  1/245 (0.41%)  0/244 (0.00%) 
Vaginal cancer  1  1/245 (0.41%)  0/244 (0.00%) 
Nervous system disorders     
Transient ischaemic attack  1  1/245 (0.41%)  3/244 (1.23%) 
Cerebral haemorrhage  1  1/245 (0.41%)  1/244 (0.41%) 
Vascular dementia  1  0/245 (0.00%)  2/244 (0.82%) 
Basilar artery thrombosis  1  0/245 (0.00%)  1/244 (0.41%) 
Carotid artery stenosis  1  0/245 (0.00%)  1/244 (0.41%) 
Carpal tunnel syndrome  1  0/245 (0.00%)  1/244 (0.41%) 
Cerebrovascular accident  1  1/245 (0.41%)  0/244 (0.00%) 
Complex regional pain syndrome  1  0/245 (0.00%)  1/244 (0.41%) 
Convulsion  1  0/245 (0.00%)  1/244 (0.41%) 
Haemorrhage intracranial  1  1/245 (0.41%)  0/244 (0.00%) 
Ischaemic neuropathy  1  0/245 (0.00%)  1/244 (0.41%) 
Myxoedema coma  1  1/245 (0.41%)  0/244 (0.00%) 
Neurodegenerative disorder  1  1/245 (0.41%)  0/244 (0.00%) 
Periodic limb movement disorder  1  0/245 (0.00%)  1/244 (0.41%) 
Syncope  1  1/245 (0.41%)  0/244 (0.00%) 
Uraemic encephalopathy  1  0/245 (0.00%)  1/244 (0.41%) 
Psychiatric disorders     
Confusional state  1  1/245 (0.41%)  0/244 (0.00%) 
Suicide attempt  1  0/245 (0.00%)  1/244 (0.41%) 
Renal and urinary disorders     
Renal failure chronic  1  0/245 (0.00%)  3/244 (1.23%) 
Renal haemorrhage  1  1/245 (0.41%)  1/244 (0.41%) 
Nephrolithiasis  1  0/245 (0.00%)  1/244 (0.41%) 
Reproductive system and breast disorders     
Female genital tract fistula  1  0/245 (0.00%)  1/244 (0.41%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/245 (0.00%)  3/244 (1.23%) 
Pulmonary oedema  1  0/245 (0.00%)  2/244 (0.82%) 
Acute pulmonary oedema  1  0/245 (0.00%)  1/244 (0.41%) 
Epistaxis  1  1/245 (0.41%)  0/244 (0.00%) 
Hypoxia  1  1/245 (0.41%)  0/244 (0.00%) 
Lung disorder  1  1/245 (0.41%)  0/244 (0.00%) 
Nasal septum deviation  1  0/245 (0.00%)  1/244 (0.41%) 
Orthopnoea  1  0/245 (0.00%)  1/244 (0.41%) 
Pulmonary hypertension  1  1/245 (0.41%)  0/244 (0.00%) 
Skin and subcutaneous tissue disorders     
Ingrowing nail  1  0/245 (0.00%)  1/244 (0.41%) 
Toxic skin eruption  1  0/245 (0.00%)  1/244 (0.41%) 
Vascular disorders     
Extremity necrosis  1  3/245 (1.22%)  2/244 (0.82%) 
Arterial occlusive disease  1  0/245 (0.00%)  4/244 (1.64%) 
Hypertensive crisis  1  1/245 (0.41%)  2/244 (0.82%) 
Hypertension  1  2/245 (0.82%)  0/244 (0.00%) 
Hypotension  1  1/245 (0.41%)  1/244 (0.41%) 
Peripheral arterial occlusive disease  1  2/245 (0.82%)  0/244 (0.00%) 
Peripheral ischaemia  1  1/245 (0.41%)  1/244 (0.41%) 
Aortic aneurysm  1  1/245 (0.41%)  0/244 (0.00%) 
Aortic aneurysm rupture  1  1/245 (0.41%)  0/244 (0.00%) 
Arterial stenosis  1  0/245 (0.00%)  1/244 (0.41%) 
Arteriosclerosis  1  0/245 (0.00%)  1/244 (0.41%) 
Arteriosclerosis obliterans  1  1/245 (0.41%)  0/244 (0.00%) 
Circulatory collapse  1  0/245 (0.00%)  1/244 (0.41%) 
Diabetic vascular disorder  1  0/245 (0.00%)  1/244 (0.41%) 
Haematoma  1  1/245 (0.41%)  0/244 (0.00%) 
Microscopic polyangiitis  1  1/245 (0.41%)  0/244 (0.00%) 
Peripheral vascular disorder  1  0/245 (0.00%)  1/244 (0.41%) 
Varicose vein  1  0/245 (0.00%)  1/244 (0.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MIRCERA Darbepoetin Alfa
Affected / at Risk (%) Affected / at Risk (%)
Total   140/245 (57.14%)   126/244 (51.64%) 
Gastrointestinal disorders     
Diarrhoea  1  17/245 (6.94%)  19/244 (7.79%) 
Nausea  1  14/245 (5.71%)  8/244 (3.28%) 
Constipation  1  16/245 (6.53%)  3/244 (1.23%) 
Infections and infestations     
Nasopharyngitis  1  25/245 (10.20%)  20/244 (8.20%) 
Urinary tract infection  1  23/245 (9.39%)  15/244 (6.15%) 
Bronchitis  1  17/245 (6.94%)  16/244 (6.56%) 
Influenza  1  13/245 (5.31%)  17/244 (6.97%) 
Injury, poisoning and procedural complications     
Procedural hypotension  1  20/245 (8.16%)  26/244 (10.66%) 
Arteriovenous fistula site complication  1  16/245 (6.53%)  15/244 (6.15%) 
Metabolism and nutrition disorders     
Fluid overload  1  9/245 (3.67%)  16/244 (6.56%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  21/245 (8.57%)  19/244 (7.79%) 
Back pain  1  13/245 (5.31%)  13/244 (5.33%) 
Vascular disorders     
Hypertension  1  35/245 (14.29%)  26/244 (10.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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: NCT00394953     History of Changes
Other Study ID Numbers: BH17847
First Submitted: November 1, 2006
First Posted: November 2, 2006
Results First Submitted: August 12, 2016
Results First Posted: January 20, 2017
Last Update Posted: January 20, 2017