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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 124
- 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)
Study Overview
Brief Summary
This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults greater than or equal to (≥) 18 years of age
- •Chronic renal anemia
- •Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
- •Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months
Exclusion Criteria
- •Transfusion of red blood cells during previous 2 months
- •Poorly controlled hypertension
- •Significant acute or chronic bleeding
Arms & Interventions
Mircera in Renal Anemia
Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.
Intervention: Methoxy polyethylene glycol-epoetin beta (Drug)
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, and -1; 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 -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. 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 10.0 to 12.0 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, and -1; 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)
- Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Number of Participants Receiving Blood Transfusion During the DTP and EEP(Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24)
- Number of Blood Transfusions During the DTP and EEP(Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24)