Phase 3
Completed N=80
A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.
Source: ClinicalTrials.gov NCT00546481 ↗Enrolled (actual)
80
Serious AEs
18.3%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 — 79.5; 87.8 Percentage of participants
Summary
This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 |
79.5; 87.8 | — |
| SECONDARY Mean Change From Baseline in Hemoglobin Concentration at Week 24 |
2.00; 2.03 | — |
| SECONDARY Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24 |
84; 72 | — |
| SECONDARY Number of Participants Who Received Red Blood Cells Transfusions up to Week 49 |
8; 2; 1 | — |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Events |
34; 39; 51; 10; 6; 8 | — |
| SECONDARY Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24 |
2.74; 2.72; -1.74; 3.87; 5.26; 2.59 | — |
| SECONDARY Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24 |
-5.39; -1.79 | — |
| SECONDARY Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24 |
3; 3 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- chronic renal anemia;
- maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.
Exclusion Criteria
- previous therapy with epoetin within 8 weeks prior to screening;
- overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
- RBC transfusions within 8 weeks before screening or during screening period;
- active malignant disease except non-melanoma skin cancer.
Data sourced from ClinicalTrials.gov (NCT00546481). 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.