A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: Methoxy polyethylene glycol-epoetin beta [Mircera]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01191983

ML25276

Details and patient eligibility

About

This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28 weeks.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetic nephropathy
• Chronic renal anemia with stage III-IV CKD
• Not on dialysis and not expected to require dialysis within the next 6 months
• Not receiving any ESA in the 2 months prior to study
• Adequate iron status

Exclusion criteria

• Transfusion of red blood cells during the previous 2 months
• Known or clinical suspicion of pure red cell aplasia
• Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
• Haemoglobinopathy
• Significant acute or chronic bleeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Methoxy polyethylene glycol-epoetin beta

Experimental group

Description:

Participants will receive 1.2 mcg/kg methoxy polyethylene glycol-epoetin beta given in monthly doses at each visit. Dose will be measured on the basis of the participants Hb level during the study period. The dose administration will be the nearest possible dose using the prefilled syringes containing 50, 75 and 100 mcg/kg Q4W.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta [Mircera]