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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: August 16, 2010
Last updated: November 2, 2015
Last verified: November 2015
This single arm, open label study will assess the efficacy, safety and tolerability of Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of renal anemia in patients with chronic kidney disease secondary to diabetes. Patients who are not on dialysis and not currently treated with erythropoiesis stimulating agents will receive Mircera subcutaneously every 4 weeks. The starting dose of 1.2 mcg/kg Mircera will be adjusted according to haemoglobin levels. Anticipated time on study treatment is 28 weeks.

Condition Intervention Phase
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Anaemia in Diabetic Nephropathy With CKD Stages III-IV Not on Dialysis, Not Currently Treated With ESA.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Correction of haemoglobin (Hb) levels and maintenance within target range (10-12 g/dL) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered sc every 4 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Diabetic nephropathy
  • Chronic renal anaemia with stage III-IV chronic kidney disease
  • Not on dialysis and not expected to require dialysis within the next 6 months
  • Not receiving any erythropoiesis stimulating agent (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191983

Contact: Reference Study ID Number: ML25276 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Ahmedabad, India, 380007
Bangalore, India, 560054
Delhi, India, 110092
Delhi, India, 110085
Hyderabad, India, 500001
Hyderabad, India, 500012
Kolkata, India, 700 020
Mumbai, India, 400097
Mumbai, India, 400076
Mumbai, India, 400 071
New Delhi, India, 110017
New Delhi, India, 110076
Pune, India, 411004
Pune, India, 411011
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01191983     History of Changes
Other Study ID Numbers: ML25276
Study First Received: August 16, 2010
Last Updated: November 2, 2015
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetic Nephropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Hematologic Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 30, 2015