A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy

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.

Sponsors

Lead Sponsor: Hoffmann-La Roche

Source Hoffmann-La Roche
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.

Overall Status Completed
Start Date August 13, 2010
Completion Date April 23, 2018
Primary Completion Date April 23, 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Outcome
Measure Time Frame
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
Enrollment 102
Condition
Intervention

Intervention Type: Drug

Intervention Name: Methoxy polyethylene glycol-epoetin beta [Mircera]

Description: Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W

Arm Group Label: Methoxy polyethylene glycol-epoetin beta

Other Name: Mircera, C.E.R.A

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche
Location
Facility:
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
Location Countries

India

Verification Date

July 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Methoxy polyethylene glycol-epoetin beta

Type: Experimental

Description: 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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov