Phase 3
N=208
A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Chronic Renal Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00550680 ↗Enrolled (actual)
208
Serious AEs
18.1%
Results posted
Mar 2016
Primary outcome: 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) — 53.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methoxy polyethylene glycol-epoetin beta (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2009
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) |
53.7 | — |
| SECONDARY Mean Change in Time-Adjusted Hb From Baseline to EEP |
0.0 | — |
| SECONDARY Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP |
53.7 | — |
| SECONDARY Mean Time Spent in the Target Range for Hb During the EEP |
34 | — |
| SECONDARY Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP |
68; 38 | — |
| SECONDARY Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion |
3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00550680). 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.