Phase 3
Completed N=673
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
Source: ClinicalTrials.gov NCT00077610 ↗Enrolled (actual)
673
Serious AEs
43.1%
Results posted
Feb 2016
Primary outcomePrimary: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period — -0.10; 0.01; -0.10 gram per deciliter (g/dL) — p=<0.0001
Summary
This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. 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 (Hb) Concentration From Baseline to Evaluation Period |
-0.10; 0.01; -0.10 | <0.0001 sig |
| SECONDARY Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration. |
133; 127; 138 | — |
| SECONDARY The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods |
21; 16; 17 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC) |
0; 1; 3; 14; 10; 6 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes |
4; 2; 5; 15; 14; 16 | — |
| SECONDARY Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 |
1; -2; 3; -0; -3; 1 | — |
| SECONDARY Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 |
1; 2; 0; 1; 1; -1 | — |
| SECONDARY Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death |
203; 202; 214; 101; 87; 99 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving IV epoetin 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 (NCT00077610). 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.