Phase 3
N=96
A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00737477 ↗Enrolled (actual)
96
Serious AEs
50.0%
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP — 50.0 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
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP |
50.0 | — |
| SECONDARY Percentage of Participants With Hb Values Within Target Range During the EEP |
78.8; 49.4; 23.0 | — |
| SECONDARY Change in Hb Value From Baseline to the EEP |
0.4 | — |
| SECONDARY Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period |
5.9; 22.0 | — |
| SECONDARY Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit |
37.5; 35.5; 44.0; 39.7; 44.4; 51.5 | — |
| SECONDARY Percentage of Participants With Cycles or Excursions |
5.3; 60.0; 46.3; 18.9 | — |
| SECONDARY Percentage of Participants With Up Excursions |
31.8; 45.5; 22.7 | — |
| SECONDARY Percentage of Participants With Down Excursions |
16.7; 11.1; 72.2 | — |
| SECONDARY Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA |
84.2; 69.3; 43.3; 34.7; 100; 74.0 | — |
| SECONDARY Number of Dose Adjustments of Mircera/CERA |
2.0; 5.6; 3.3 | — |
| SECONDARY Absolute Change in Dose of Mircera/CERA by Study Week |
25.8; 37.8; 28.4; 42.9; 24.5; 52.5 | — |
| SECONDARY Percent Change in Dose of Mircera/CERA by Study Week |
23.7; 22.2; 33.3; 21.4; 30.3; 22.0 | — |
| SECONDARY Percentage of Participants Requiring Blood Transfusions |
3.2 | — |
Summary
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.
Eligibility Criteria
Inclusion Criteria
- Adults greater than or equal to (≥) 18 years of age
- Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months
- Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start
Exclusion Criteria
- Transfusion of red blood cells during previous 8 weeks
- Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months
- Significant acute or chronic bleeding during previous 8 weeks
Data sourced from ClinicalTrials.gov (NCT00737477). 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.