Phase 3
Completed N=101
A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia
Source: ClinicalTrials.gov NCT00605293 ↗Enrolled (actual)
101
Serious AEs
19.8%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP — 45.45; 55.17 percentage of participants — p=0.4778
Summary
This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP |
45.45; 55.17 | 0.4778 |
| SECONDARY Change in Hb Concentrations Between Baseline SVP and the EEP |
-0.35; 0.32 | — |
| SECONDARY Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP |
32.7; 40.6 | — |
| SECONDARY Mean Time Spent in Hb Range 10-12 g/dL |
26.7; 27.1; 67.5; 72.9; 32.2; 28.9 | — |
| SECONDARY Percentage of Participants Who Required Dose Adjustments During the DTP and EEP |
30.8; 44.4; 67.7; 55.6; 18.5; 19.4 | — |
| SECONDARY Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP |
12.3; 2.8 | — |
Eligibility Criteria
Inclusion Criteria
- chronic renal anemia;
- continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
- regular hemodialysis for greater than or equal to (>=) 3 months
Exclusion Criteria
- transfusion of red blood cells during previous 2 months
- poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;
Data sourced from ClinicalTrials.gov (NCT00605293). 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.