A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 490
- Primary Endpoint
- 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
Study Overview
Brief Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients, >=18 years of age;
- •chronic renal anemia;
- •hemodialysis 3 times weekly for >=12 weeks before screening, and during screening/baseline period;
- •receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.
Exclusion Criteria
- •overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
- •transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
- •active malignancy;
Arms & Interventions
MIRCERA
Eligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Darbepoetin Alfa
Eligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Intervention: Darbepoetin alfa (Drug)
Outcomes
Primary Outcomes
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
Time Frame: Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)
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.
Secondary Outcomes
- Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time(Week 27 to Month 12)
- Number of Participants With Marked Laboratory Abnormality Over Time(Up to Week 53)
- Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths(From screening to Week 56)
- Mean Pulse Rate Over Time(Baseline (Week -4 to Week -1), Week 28, and Week 52)
- Median Blood Pressure Over Time(Baseline (Week -4 to Week -1), Week 28, and Week 52)