Trial Outcomes & Findings for A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease. (NCT NCT00422513)
NCT ID: NCT00422513
Last Updated: 2011-12-14
Results Overview
Efficacy and pharmacoeconomics analyses were not performed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
260 participants
Primary outcome timeframe
Months 5-7
Results posted on
2011-12-14
Participant Flow
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
120-360 micrograms intravenous (iv) monthly, starting dose
|
Epoetin Alfa
As prescribed, (iv), 3 times weekly
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
130
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
107
|
106
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
120-360 micrograms intravenous (iv) monthly, starting dose
|
Epoetin Alfa
As prescribed, (iv), 3 times weekly
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
5
|
|
Overall Study
Protocol Violation
|
23
|
7
|
|
Overall Study
Refused Treatment
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
early termination of the study
|
67
|
80
|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Death
|
3
|
7
|
Baseline Characteristics
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=123 Participants
120-360 micrograms (iv) monthly, starting dose
|
Epoetin Alfa
n=129 Participants
As prescribed, (iv), 3 times weekly
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.3 years
STANDARD_DEVIATION 13.90 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 14.06 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 13.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Months 5-7Population: The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.
Efficacy and pharmacoeconomics analyses were not performed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Months 5-7Population: The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.
Efficacy and pharmacoeconomics analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 1 to 15 day follow up post month 7Population: Safety Population
The adverse events are captured in the adverse event and serious adverse event section of this database.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=123 Participants
120-360 micrograms (iv) monthly, starting dose
|
Epoetin Alfa
n=129 Participants
As prescribed, (iv), 3 times weekly
|
|---|---|---|
|
Number of Participants Assessed for AEs
|
123 number of participants
|
129 number of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1 to Month 7Population: Safety Population
A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=123 Participants
120-360 micrograms (iv) monthly, starting dose
|
Epoetin Alfa
n=129 Participants
As prescribed, (iv), 3 times weekly
|
|---|---|---|
|
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Hematocrit - low
|
32 number of participants
|
24 number of participants
|
|
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Hemoglobin - low
|
36 number of participants
|
28 number of participants
|
|
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Platelets - low
|
9 number of participants
|
4 number of participants
|
|
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Creatine Phosphokinase - high
|
4 number of participants
|
8 number of participants
|
|
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Potassium - high
|
20 number of participants
|
20 number of participants
|
|
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Fasting Glusose - high
|
20 number of participants
|
20 number of participants
|
|
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Phosphate - high
|
52 number of participants
|
48 number of participants
|
|
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Phosphate - low
|
9 number of participants
|
12 number of participants
|
Adverse Events
Methoxy Polyethylene Glycol-epoetin Beta
Serious events: 24 serious events
Other events: 15 other events
Deaths: 0 deaths
Epoetin Alfa
Serious events: 38 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=123 participants at risk
120-360 micrograms (iv) monthly, starting dose
|
Epoetin Alfa
n=129 participants at risk
As prescribed, (iv), 3 times weekly
|
|---|---|---|
|
Cardiac disorders
cardiac failure congestive
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
8.5%
11/129 • Month 1 to 15 day follow up post month 7
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
2.3%
3/129 • Month 1 to 15 day follow up post month 7
|
|
Cardiac disorders
coronary artery disease
|
1.6%
2/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Cardiac disorders
cardiac arrest
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Cardiac disorders
acute coronary syndrome
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Cardiac disorders
coronary artery occlusion
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Cardiac disorders
sick sinus syndrome
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Cardiac disorders
ventricular fibrillation
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Infections and infestations
pneumonia
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
2.3%
3/129 • Month 1 to 15 day follow up post month 7
|
|
Infections and infestations
arteriovenous graft site infection
|
1.6%
2/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Infections and infestations
bacterial sepsis
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
1.6%
2/129 • Month 1 to 15 day follow up post month 7
|
|
Infections and infestations
bronchitis
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Infections and infestations
gastroenteritis viral
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Infections and infestations
pseudomembranous colitis
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Infections and infestations
pyelonephritis
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Infections and infestations
vulval abscess
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
appendiccal mucocoele
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
colitis ischaemic
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
colonic pseudo-obstruction
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
diabetic gastropathy
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
gastric ulcer
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
gastrointestinal haemorrhage
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
haemorrhoidal haemorrhage
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
peptic ulcer
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Metabolism and nutrition disorders
diabetes mellitus inadequate control
|
1.6%
2/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Metabolism and nutrition disorders
fluid overload
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Metabolism and nutrition disorders
hypercalcaemia
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Metabolism and nutrition disorders
hypoglycaemic unconsciousness
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Vascular disorders
hypertension
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
1.6%
2/129 • Month 1 to 15 day follow up post month 7
|
|
Vascular disorders
malignant hypertension
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Vascular disorders
peripheral vascular disorder
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Vascular disorders
thrombosis
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Vascular disorders
vascular calcification
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Vascular disorders
vascular pseudoaneurysm ruptured
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Injury, poisoning and procedural complications
arteriovenous fistula thrombosis
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Injury, poisoning and procedural complications
arteriovenous graft thrombosis
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Injury, poisoning and procedural complications
hand fracture
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Injury, poisoning and procedural complications
lower limb fracture
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Injury, poisoning and procedural complications
overdose
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Injury, poisoning and procedural complications
procedural hypotension
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Injury, poisoning and procedural complications
subdural haemorrhage
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
1.6%
2/123 • Month 1 to 15 day follow up post month 7
|
2.3%
3/129 • Month 1 to 15 day follow up post month 7
|
|
Injury, poisoning and procedural complications
pleural effusion
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Respiratory, thoracic and mediastinal disorders
respiratory arrest
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
General disorders
chest pain
|
1.6%
2/123 • Month 1 to 15 day follow up post month 7
|
1.6%
2/129 • Month 1 to 15 day follow up post month 7
|
|
General disorders
fatigue
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
1.6%
2/129 • Month 1 to 15 day follow up post month 7
|
|
Nervous system disorders
headache
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
1.6%
2/129 • Month 1 to 15 day follow up post month 7
|
|
Nervous system disorders
convulsion
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Nervous system disorders
cerebrovascular accident
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Nervous system disorders
tremor
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Psychiatric disorders
depression
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Psychiatric disorders
mental status change
|
1.6%
2/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Psychiatric disorders
suicide attempt
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Renal and urinary disorders
calculus urinary
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
|
Renal and urinary disorders
renal colic
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Blood and lymphatic system disorders
anaemia
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Endocrine disorders
hyperparathyroidism
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colon cancer
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
0.78%
1/129 • Month 1 to 15 day follow up post month 7
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
0.00%
0/129 • Month 1 to 15 day follow up post month 7
|
Other adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=123 participants at risk
120-360 micrograms (iv) monthly, starting dose
|
Epoetin Alfa
n=129 participants at risk
As prescribed, (iv), 3 times weekly
|
|---|---|---|
|
General disorders
oedema peripheral
|
7.3%
9/123 • Month 1 to 15 day follow up post month 7
|
6.2%
8/129 • Month 1 to 15 day follow up post month 7
|
|
Gastrointestinal disorders
diarrhoea
|
4.1%
5/123 • Month 1 to 15 day follow up post month 7
|
6.2%
8/129 • Month 1 to 15 day follow up post month 7
|
|
General disorders
face oedema
|
4.9%
6/123 • Month 1 to 15 day follow up post month 7
|
5.4%
7/129 • Month 1 to 15 day follow up post month 7
|
|
Respiratory, thoracic and mediastinal disorders
breath sounds abnormal
|
3.3%
4/123 • Month 1 to 15 day follow up post month 7
|
5.4%
7/129 • Month 1 to 15 day follow up post month 7
|
|
General disorders
pain in extremity
|
3.3%
4/123 • Month 1 to 15 day follow up post month 7
|
5.4%
7/129 • Month 1 to 15 day follow up post month 7
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.81%
1/123 • Month 1 to 15 day follow up post month 7
|
5.4%
7/129 • Month 1 to 15 day follow up post month 7
|
|
General disorders
back pain
|
0.00%
0/123 • Month 1 to 15 day follow up post month 7
|
5.4%
7/129 • Month 1 to 15 day follow up post month 7
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee "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
- Publication restrictions are in place
Restriction type: OTHER