An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.
Overview
- Phase
- Phase 3
- Intervention
- Mircera
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 228
- Primary Endpoint
- Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. 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 kidney disease, not requiring dialysis;
- •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 malignant disease;
- •previous treatment with Mircera.
Arms & Interventions
Mircera
Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
Intervention: Mircera
Darbepoetin alfa
Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
Intervention: Darbepoetin alfa
Outcomes
Primary Outcomes
Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
Time Frame: Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).
A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
Secondary Outcomes
- Change in Hemoglobin Concentration From Baseline Over Time(From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.)
- Number of Participants With Red Blood Cell (RBC) Transfusions(From randomization to Month 9)
- Participants With Adverse Events(Randomization to Month 10 (final visit))