A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis
Overview
- Phase
- Phase 3
- Intervention
- methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 20
- Locations
- 23
- Primary Endpoint
- Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic renal anemia
- •Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks
Exclusion Criteria
- •Transfusion of red blood cells during previous 8 weeks
- •Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
- •Acute or chronic bleeding requiring therapy within previous 8 weeks
Arms & Interventions
methoxy polyethylene glycol-epoetin beta
Intervention: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Outcomes
Primary Outcomes
Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
Time Frame: EEP (Weeks 16 to 24)
The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.
Secondary Outcomes
- Percentage of Participants With Dose Adjustment(Baseline up to Week 20)
- Mean Change in Hb Concentration Between SVP and the EEP(SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24))
- Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP(EEP (Weeks 16 to 24))
- Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP(EEP (Weeks 16 to 24))
- Percentage of Participants With Blood Transfusion(Baseline up to Week 28)