A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy
- Conditions
- Anemia
- Interventions
- Drug: Methoxy polyethylene glycol-epoetin beta [Mircera]
- Registration Number
- NCT01191983
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Methoxy polyethylene glycol-epoetin beta Methoxy polyethylene glycol-epoetin beta [Mircera] 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.
- Primary Outcome Measures
Name Time Method Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP) EEP (Week 17 up to Week 24) Change in Hb Concentration Between Baseline and EEP Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24) Percentage of Participants Maintaining Hb Concentration Within the Target Range (10-12 g/dL) During EEP EEP: (Week 17 up to Week 24)
- Secondary Outcome Measures
Name Time Method Short Form-36 Health Survey (SF-36) score Week 0 to Week 24 Percentage of Participants With Adverse Events Baseline (Week -2 up to Week 0) to Week 28 Percentage of Participants With Red Blood Cell Transfusion During Treatment Period Week 0 up to Week 24 Percentage of Participants with anti-epoetin antibodies Baseline (Week-2 up to Week 0) up to Week 28
Trial Locations
- Locations (14)
Osmania General Hospital; Department of Nephrology
🇮🇳Hyderabad, Andhra Pradesh, India
North Delhi Diabetes Centre
🇮🇳Delhi, India
MAX Balaji Hospital
🇮🇳Delhi, India
Apex Kidney Care Pvt. Ltd., Sushrut Hospital
🇮🇳Mumbai, India
Sanjeevani Hospital
🇮🇳Mumbai, India
Diab Care Centre
🇮🇳Mumbai, India
Pushpawati Singhania Research Institute; Nephrology
🇮🇳New Delhi, Delhi, India
M S Ramaiah Memorial Hospital
🇮🇳Bangalore, India
Vijayratna Diabetes Diagnosis & Treatment Center
🇮🇳Ahmedabad, India
IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre
🇮🇳Kolkata, India
Indraprastha Apollo Hospitals
🇮🇳New Delhi, Delhi, India
Sahyadri Speciality Hospital
🇮🇳Pune, India
Dr.Modi's Clinic
🇮🇳Hyderabad, India
Diabetes Care & Research Centre
🇮🇳Pune, India