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

NCT01191983

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Anemia

Interventions: Methoxy polyethylene glycol-epoetin beta [Mircera]

Countries: India

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (14)

Hyderabad, Andhra Pradesh, India
New Delhi, National Capital Territory of Delhi, India
New Delhi, National Capital Territory of Delhi, India
Ahmedabad, India
Bangalore, India
Delhi, India
Delhi, India
Hyderabad, India
Kolkata, India
Mumbai, India
Mumbai, India
Mumbai, India
Pune, India
Pune, India