Phase 3
N=184
A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00559637 ↗Enrolled (actual)
184
Serious AEs
47.8%
Results posted
Apr 2016
Primary outcome: Primary: Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL) — 10.67 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
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL) |
10.67 | — |
| PRIMARY Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL |
29.21 | — |
| PRIMARY Change From Baseline in Hemoglobin Value to the Evaluation Phase |
1.6 | — |
| SECONDARY Duration of Hemoglobin Values in the Range of 11-12 g/dL |
2.40 | — |
| SECONDARY Duration of Hemoglobin Values in the Range of 11-13 g/dL |
3.62 | — |
| SECONDARY Time to Increase of Hemoglobin Value to Over 11 g/dL |
2.28 | — |
| SECONDARY Total Number of Dose Adjustments |
595; 249; 210; 136 | — |
| SECONDARY Total Number of Red Blood Cell (RBC) Transfusions |
39 | — |
Summary
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- chronic renal anemia;
- hemoglobin value less than or equal to (<=) 10.5 grams/deciliter (g/dL).
Exclusion Criteria
- prior ESA therapy during previous 3 months;
- acute or chronic bleeding requiring therapy during previous 2 months;
- transfusion of red blood cells during previous 2 months;
- active malignant disease (except non-melanoma skin cancer).
Data sourced from ClinicalTrials.gov (NCT00559637). 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.