An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.
Overview
- Phase
- Phase 3
- Intervention
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 424
- Primary Endpoint
- Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patients, \>=18 years of age;
- •chronic renal anemia;
- •longterm hemodialysis for \>=12 weeks before screening;
- •baseline Hb between 10 and 13g/dL;
- •iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for \>=4 weeks before screening.
Exclusion Criteria
- •acute or chronic bleeding within 8 weeks prior to screening;
- •transfusion of red blood cells within 8 weeks prior to screening;
- •poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
- •previous treatment with Mircera.
Arms & Interventions
1
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Outcomes
Primary Outcomes
Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase
Time Frame: Visits 8 to 10 (Months 6 to 8)
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase
Time Frame: Visits 8 to 10 (Months 6 to 8)
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase
Time Frame: Visits 8 to 10 (Months 6 to 8)
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase
Time Frame: Visits 8 to 10 (Months 6 to 8)
Secondary Outcomes
- Percentage of Participants Requiring Erythrocyte Transfusions(Visits 1 to 10 (Months -2 to 8))
- Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase(Visits 1 to 2 (Months -2 to -1))
- Percentage of Participants With Hb Fluctuations Within Evaluation Phase(Visits 8 to 10 (Months 6 to 8))
- Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase(Visits 1 to 2 (Months -2 to -1))
- Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase(Visits 1 to 2 (Months -2 to -1))
- Percentage of Participants With Hb Fluctuations Within Screening Phase(Visits 1 to 2 (Months -2 to -1))
- Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase(Visits 1 to 2 (Months -2 to -1))
- Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels(Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8))