Clinical trial NCT01191983: A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy
Official title: A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Disease Stages III-IV Not on Dialysis, Not Currently Treated With ESA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-31
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)
timeFrame: EEP (Week 17 up to Week 24)
measure: Change in Hb Concentration Between Baseline and EEP
timeFrame: Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24)
measure: Percentage of Participants Maintaining Hb Concentration Within the Target Range (10-12 g/dL) During EEP
timeFrame: EEP: (Week 17 up to Week 24)
Secondary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline (Week -2 up to Week 0) to Week 28
measure: Percentage of Participants With Red Blood Cell Transfusion During Treatment Period
timeFrame: Week 0 up to Week 24
measure: Percentage of Participants with anti-epoetin antibodies
timeFrame: Baseline (Week-2 up to Week 0) up to Week 28
measure: Short Form-36 Health Survey (SF-36) score
timeFrame: Week 0 to Week 24
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Osmania General Hospital; Department of Nephrology
state: Andhra Pradesh
city: New Delhi
country: India
facility: Pushpawati Singhania Research Institute; Nephrology
state: Delhi
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
state: Delhi
city: Ahmedabad
country: India
facility: Vijayratna Diabetes Diagnosis & Treatment Center
city: Bangalore
country: India
facility: M S Ramaiah Memorial Hospital
city: Delhi
country: India
facility: North Delhi Diabetes Centre
city: Delhi
country: India
facility: MAX Balaji Hospital
city: Hyderabad
country: India
facility: Dr.Modi's Clinic
city: Kolkata
country: India
facility: IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre
city: Mumbai
country: India
facility: Apex Kidney Care Pvt. Ltd., Sushrut Hospital
city: Mumbai
country: India
facility: Diab Care Centre
city: Mumbai
country: India
facility: Sanjeevani Hospital
city: Pune
country: India
facility: Sahyadri Speciality Hospital
city: Pune
country: India
facility: Diabetes Care & Research Centre
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: