A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Methoxy Polyethylene Glycol-epoetin Beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642967

2007-005757-28

ML21146

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
• continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.

Exclusion criteria

• transfusion of red blood cells during previous 2 months;
• significant acute or chronic bleeding;
• poorly controlled hypertension.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

127 participants in 1 patient group

Methoxy Polyethylene Glycol-epoetin Beta

Experimental group

Description:

Participants will receive subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.

Treatment:

Drug: Methoxy Polyethylene Glycol-epoetin Beta