Phase 3
Completed N=124
A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
Source: ClinicalTrials.gov NCT00660023 ↗Enrolled (actual)
124
Serious AEs
39.5%
Results posted
Mar 2016
Primary outcomePrimary: 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) — 72.7 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
72.7 | — |
| SECONDARY Mean Change in Time-Adjusted Hb From Baseline to EEP |
-0.06 | — |
| SECONDARY Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP |
79.0 | — |
| SECONDARY Mean Time Spent in the Target Range for Hb During the EEP |
43.5 | — |
| SECONDARY Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP |
113; 100.3 | — |
| SECONDARY Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP |
79.8; 48.2 | — |
| SECONDARY Number of Participants Receiving Blood Transfusion During the DTP and EEP |
3; 0 | — |
| SECONDARY Number of Blood Transfusions During the DTP and EEP |
4; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00660023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.