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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W
Osmania General Hospital; Department of Nephrology
Hyderabad, Andhra Pradesh, India
Pushpawati Singhania Research Institute; Nephrology
New Delhi, National Capital Territory of Delhi, India
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India
Vijayratna Diabetes Diagnosis & Treatment Center
Ahmedabad, India
M S Ramaiah Memorial Hospital
Bangalore, India
North Delhi Diabetes Centre
Delhi, India
MAX Balaji Hospital
Delhi, India
Dr.Modi's Clinic
Hyderabad, India
IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre
Kolkata, India
Apex Kidney Care Pvt. Ltd., Sushrut Hospital
Mumbai, India
...and 4 more locations
Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)
Time frame: EEP (Week 17 up to Week 24)
Change in Hb Concentration Between Baseline and EEP
Time frame: 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
Time frame: EEP: (Week 17 up to Week 24)
Percentage of Participants With Adverse Events
Time frame: Baseline (Week -2 up to Week 0) to Week 28
Percentage of Participants With Red Blood Cell Transfusion During Treatment Period
Time frame: Week 0 up to Week 24
Percentage of Participants with anti-epoetin antibodies
Time frame: Baseline (Week-2 up to Week 0) up to Week 28
Short Form-36 Health Survey (SF-36) score
Time frame: Week 0 to Week 24
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