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 August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01191983
First received: August 16, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This single arm, open label study will assess the efficacy, safety and tolerabil ity of Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of r enal anemia in patients with chronic kidney disease secondary to diabetes. Patie nts who are not on dialysis and not currently treated with erythropoiesis stimul ating agents will receive Mircera subcutaneously every 4 weeks. The starting dos e of 1.2 mcg/kg Mircera will be adjusted according to haemoglobin levels. Antic ipated time on study treatment is 28 weeks.


Condition Intervention Phase
Anemia
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: July 2015
Estimated Primary Completion Date: July 2015 (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

  Eligibility

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

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

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

Locations
India
Recruiting
Ahmedabad, India, 380007
Recruiting
Bangalore, India, 560054
Completed
Delhi, India, 110085
Active, not recruiting
Delhi, India, 110092
Completed
Hyderabad, India, 500001
Recruiting
Hyderabad, India, 500012
Completed
Kolkata, India, 700 020
Active, not recruiting
Mumbai, India, 400076
Active, not recruiting
Mumbai, India, 400097
Suspended
Mumbai, India, 400 071
Recruiting
New Delhi, India, 110017
Active, not recruiting
New Delhi, India, 110076
Active, not recruiting
Pune, India, 411011
Completed
Pune, India, 411004
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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: August 4, 2014
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014