Phase 3
Completed N=313
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Source: ClinicalTrials.gov NCT00077766 ↗Enrolled (actual)
313
Serious AEs
47.3%
Results posted
Sep 2016
Primary outcomePrimary: Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period — 0.05; -0.10 gram per deciliter (g/dL) — p=< 0.0001
Summary
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period |
0.05; -0.10 | < 0.0001 sig |
| SECONDARY Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration |
91; 102 | — |
| SECONDARY Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods |
19; 16 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
0; 6; 6; 4; 4; 3 | — |
| SECONDARY Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 |
-2; -2; -0; -2; 2; -4 | — |
| SECONDARY Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 |
-1; 1; -1; 0 | — |
| SECONDARY Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths |
135; 143; 71; 75; 13; 12 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving darbepoetin alfa iv for at least 8 weeks before screening.
Exclusion Criteria
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or during the study period.
Data sourced from ClinicalTrials.gov (NCT00077766). 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.