Status:
COMPLETED
A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 k...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2018
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01191983
Start Date
August 13 2010
End Date
April 23 2018
Last Update
July 18 2018
Active Locations (14)
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1
Osmania General Hospital; Department of Nephrology
Hyderabad, Andhra Pradesh, India, 500012
2
Pushpawati Singhania Research Institute; Nephrology
New Delhi, National Capital Territory of Delhi, India, 110017
3
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India, 110076
4
Vijayratna Diabetes Diagnosis & Treatment Center
Ahmedabad, India, 380007