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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191983
First Posted: August 31, 2010
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Anemia in Diabetic Nephropathy With Chronic Kidney Disease 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:
  • 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) ]
  • Change in Hb Concentration Between Baseline and EEP [ Time Frame: 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) ]

Secondary Outcome Measures:
  • Percentage of Participants With Adverse Events [ Time Frame: 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 ]
  • Percentage of Participants with anti-epoetin antibodies [ Time Frame: 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 ]

Enrollment: 102
Actual Study Start Date: August 13, 2010
Estimated Study Completion Date: July 19, 2018
Estimated Primary Completion Date: July 19, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mircera, C.E.R.A

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191983


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01191983     History of Changes
Other Study ID Numbers: ML25276
First Submitted: August 16, 2010
First Posted: August 31, 2010
Last Update Posted: November 1, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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