A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy
NCT ID: NCT01191983
Last Updated: 2018-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
102 participants
INTERVENTIONAL
2010-08-13
2018-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Methoxy polyethylene glycol-epoetin beta
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.
Methoxy polyethylene glycol-epoetin beta [Mircera]
Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W
Interventions
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Methoxy polyethylene glycol-epoetin beta [Mircera]
Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Diab Care Centre
Mumbai, , India
Sanjeevani Hospital
Mumbai, , India
Sahyadri Speciality Hospital
Pune, , India
Diabetes Care & Research Centre
Pune, , India
Countries
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Other Identifiers
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ML25276
Identifier Type: -
Identifier Source: org_study_id
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