Phase 3
Completed N=572
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
Source: ClinicalTrials.gov NCT00077623 ↗Enrolled (actual)
572
Serious AEs
39.9%
Results posted
Apr 2016
Primary outcomePrimary: Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods — -0.00; -0.11; -0.12 g/dL — p=<0.0001
Summary
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc 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 Concentration From Baseline to Evaluation Periods |
-0.00; -0.11; -0.12 | <0.0001 sig |
| SECONDARY Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration |
124; 111; 127 | — |
| SECONDARY Number of Participants With Red Blood Cell Transfusions |
12; 20; 19 | — |
| SECONDARY Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths |
171; 177; 167; 70; 73; 85 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
0; 1; 1; 8; 11; 1 | — |
| SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants |
0; 0; 1; -1; -1; 2 | — |
| SECONDARY Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants |
-0; 1; -0; -0; 1; -0 | — |
| SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants |
2; -7; 2; 1; -8; 2 | — |
| SECONDARY Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants |
1; 4; 6; -3; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving sc 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 (NCT00077623). 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.