A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Overview
- Phase
- Phase 3
- Intervention
- Methoxy polyethylene glycol-epoetin beta
- Conditions
- Chronic Renal Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 208
- Primary Endpoint
- Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults greater than or equal to (≥) 18 years of age
- •Chronic renal anemia
- •Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
- •Hemodialysis therapy for ≥3 months
Exclusion Criteria
- •Transfusion of red blood cells during previous 2 months
- •Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
- •Acute or chronic bleeding
Arms & Interventions
Mircera in Renal Anemia
Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 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. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
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 and Within Target Range During the Efficacy Evaluation Period (EEP)
Time Frame: Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 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 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. 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 target range of 10.5 to 12.5 g/dL 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 Change in Time-Adjusted Hb From Baseline to EEP(At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
- Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP(Pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
- Mean Time Spent in the Target Range for Hb During the EEP(Pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
- Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion(Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24)