A Single Arm, Open Label, Interventional Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Hemoglobin Levels in Hemodialysis Patients With Chronic Renal Anemia
Overview
- Phase
- Phase 3
- Intervention
- Methoxy polyethylene glycol-epoetin beta
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 120
- Primary Endpoint
- Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent [ESA] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter [g/dL] for Switzerland and 10 to 12 g/dL for Austria).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults greater than or equal to (≥) 18 years of age
- •Chronic renal anemia
- •Hemoglobin concentration in country-specific target range (Switzerland: 11 to 13 g/dL; Austria: 10 to 12 g/dL)
- •Regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months
- •Continuous intravenous or subcutaneous maintenance ESA treatment during previous 2 months
Exclusion Criteria
- •Transfusion of red blood cells during previous 2 months
- •Significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- •Active malignant disease (except non-melanoma skin cancer)
Arms & Interventions
Mircera in Renal Anemia
Participants will receive intravenous Mircera every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.
Intervention: Methoxy polyethylene glycol-epoetin beta
Outcomes
Primary Outcomes
Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)
Time Frame: At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
Secondary Outcomes
- Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP(Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48)
- Mean Change in Time-Adjusted Hb From Baseline to EEP(At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24)
- Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP(Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24)
- Percentage of Hb Values Above or Below the Target Range During the LTSP(Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48)
- Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)(Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48)
- Mean Time Spent Above or Below the Target Range for Hb During the LTSP(Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48)
- Mean Excursions Above or Below Target Range for Hb During the LTSP(Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48)
- Mean Dose of Mircera/CERA During the DTP and LTSP(Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48)
- Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP(From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52)