An Open-label, Randomized, Multi-center, Parallel Group Study to Demonstrate Correction of Anemia Using Intravenous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are on Dialysis
Overview
- Phase
- Phase 3
- Intervention
- methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 80
- Primary Endpoint
- Percentage of Participants Who Achieved Hemoglobin Response up to Week 24
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patients, \>=18 years of age;
- •chronic renal anemia;
- •maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before screening, and during screening period.
Exclusion Criteria
- •previous therapy with epoetin within 8 weeks prior to screening;
- •overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
- •RBC transfusions within 8 weeks before screening or during screening period;
- •active malignant disease except non-melanoma skin cancer.
Arms & Interventions
Correction Phase: CERA
Intervention: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]
Correction Phase: Epoetin Beta
Intervention: Epoetin
Outcomes
Primary Outcomes
Percentage of Participants Who Achieved Hemoglobin Response up to Week 24
Time Frame: Up to Week 24
Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb\>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented
Secondary Outcomes
- Mean Change From Baseline in Hemoglobin Concentration at Week 24(From Baseline (Day 1) to Week 24)
- Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24(Up to Week 24)
- Number of Participants Who Received Red Blood Cells Transfusions up to Week 49(Up to Week 49)
- Number of Participants With Any Adverse Events and Serious Adverse Events(Up to Week 49)
- Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24(From Baseline (Day 1) to Week 24)
- Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24(From Baseline (Day 1) to Week 24)
- Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24(Up to Week 24)