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

July 17, 2018 updated by: Hoffmann-La Roche

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India, 380007
        • Vijayratna Diabetes Diagnosis & Treatment Center
      • Bangalore, India, 560054
        • M S Ramaiah Memorial Hospital
      • Delhi, India, 110085
        • North Delhi Diabetes Centre
      • Delhi, India, 110092
        • MAX Balaji Hospital
      • Hyderabad, India, 500001
        • Dr.Modi's Clinic
      • Kolkata, India, 700 020
        • IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre
      • Mumbai, India, 400 071
        • Apex Kidney Care Pvt. Ltd., Sushrut Hospital
      • Mumbai, India, 400076
        • Diab Care Centre
      • Mumbai, India, 400097
        • Sanjeevani Hospital
      • Pune, India, 411004
        • Sahyadri Speciality Hospital
      • Pune, India, 411011
        • Diabetes Care & Research Centre
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500012
        • Osmania General Hospital; Department of Nephrology
    • Delhi
      • New Delhi, Delhi, India, 110076
        • Indraprastha Apollo Hospitals
      • New Delhi, Delhi, India, 110017
        • Pushpawati Singhania Research Institute; Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Methoxy polyethylene glycol-epoetin beta [Mircera]
Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W
Other Names:
  • Mircera, C.E.R.A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
EEP: (Week 17 up to Week 24)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events
Time Frame: Baseline (Week -2 up to Week 0) to Week 28
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
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
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
Week 0 to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2010

Primary Completion (Actual)

April 23, 2018

Study Completion (Actual)

April 23, 2018

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (Estimate)

August 31, 2010

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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