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Clinical Trial Details

Trial ID: L1558
Source ID: NCT01191983
Associated Drug: Methoxy Polyethylene Glycol-Epoetin Beta [Mircera]
Title: A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia
Interventions: DRUG: Methoxy polyethylene glycol-epoetin beta [Mircera]
Outcome Measures: Primary: 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: 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|Short Form-36 Health Survey (SF-36) score, Week 0 to Week 24
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 102
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-08-13
Completion Date: 2018-04-23
Results First Posted:
Last Update Posted: 2018-07-18
Locations: Osmania General Hospital; Department of Nephrology, Hyderabad, Andhra Pradesh, 500012, India|Pushpawati Singhania Research Institute; Nephrology, New Delhi, Delhi, 110017, India|Indraprastha Apollo Hospitals, New Delhi, Delhi, 110076, India|Vijayratna Diabetes Diagnosis & Treatment Center, Ahmedabad, 380007, India|M S Ramaiah Memorial Hospital, Bangalore, 560054, India|North Delhi Diabetes Centre, Delhi, 110085, India|MAX Balaji Hospital, Delhi, 110092, India|Dr.Modi's Clinic, Hyderabad, 500001, India|IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre, Kolkata, 700 020, India|Apex Kidney Care Pvt. Ltd., Sushrut Hospital, Mumbai, 400 071, India|Diab Care Centre, Mumbai, 400076, India|Sanjeevani Hospital, Mumbai, 400097, India|Sahyadri Speciality Hospital, Pune, 411004, India|Diabetes Care & Research Centre, Pune, 411011, India
URL: https://clinicaltrials.gov/show/NCT01191983