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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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Methoxy polyethylene glycol-epoetin beta [Mircera]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osmania General Hospital; Department of Nephrology
  • Pushpawati Singhania Research Institute; Nephrology
  • Indraprastha Apollo Hospitals
  • Vijayratna Diabetes Diagnosis & Treatment Center
  • M S Ramaiah Memorial Hospital
  • North Delhi Diabetes Centre
  • MAX Balaji Hospital
  • Dr.Modi's Clinic
  • IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre
  • Apex Kidney Care Pvt. Ltd., Sushrut Hospital
  • Diab Care Centre
  • Sanjeevani Hospital
  • Sahyadri Speciality Hospital
  • Diabetes Care & Research Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methoxy polyethylene glycol-epoetin beta

Arm 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.

Outcomes

Primary Outcome Measures

Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)
Change in Hb Concentration Between Baseline and EEP
Percentage of Participants Maintaining Hb Concentration Within the Target Range (10-12 g/dL) During EEP

Secondary Outcome Measures

Percentage of Participants With Adverse Events
Percentage of Participants With Red Blood Cell Transfusion During Treatment Period
Percentage of Participants with anti-epoetin antibodies
Short Form-36 Health Survey (SF-36) score

Full Information

First Posted
August 16, 2010
Last Updated
July 17, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01191983
Brief Title
A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 13, 2010 (Actual)
Primary Completion Date
April 23, 2018 (Actual)
Study Completion Date
April 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methoxy polyethylene glycol-epoetin beta
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Methoxy polyethylene glycol-epoetin beta [Mircera]
Other Intervention Name(s)
Mircera, C.E.R.A
Intervention Description
Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W
Primary Outcome Measure Information:
Title
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)
Title
Change in Hb Concentration Between Baseline and EEP
Time Frame
Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24)
Title
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 Measure Information:
Title
Percentage of Participants With Adverse Events
Time Frame
Baseline (Week -2 up to Week 0) to Week 28
Title
Percentage of Participants With Red Blood Cell Transfusion During Treatment Period
Time Frame
Week 0 up to Week 24
Title
Percentage of Participants with anti-epoetin antibodies
Time Frame
Baseline (Week-2 up to Week 0) up to Week 28
Title
Short Form-36 Health Survey (SF-36) score
Time Frame
Week 0 to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Osmania General Hospital; Department of Nephrology
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500012
Country
India
Facility Name
Pushpawati Singhania Research Institute; Nephrology
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Indraprastha Apollo Hospitals
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Vijayratna Diabetes Diagnosis & Treatment Center
City
Ahmedabad
ZIP/Postal Code
380007
Country
India
Facility Name
M S Ramaiah Memorial Hospital
City
Bangalore
ZIP/Postal Code
560054
Country
India
Facility Name
North Delhi Diabetes Centre
City
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
MAX Balaji Hospital
City
Delhi
ZIP/Postal Code
110092
Country
India
Facility Name
Dr.Modi's Clinic
City
Hyderabad
ZIP/Postal Code
500001
Country
India
Facility Name
IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre
City
Kolkata
ZIP/Postal Code
700 020
Country
India
Facility Name
Apex Kidney Care Pvt. Ltd., Sushrut Hospital
City
Mumbai
ZIP/Postal Code
400 071
Country
India
Facility Name
Diab Care Centre
City
Mumbai
ZIP/Postal Code
400076
Country
India
Facility Name
Sanjeevani Hospital
City
Mumbai
ZIP/Postal Code
400097
Country
India
Facility Name
Sahyadri Speciality Hospital
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Diabetes Care & Research Centre
City
Pune
ZIP/Postal Code
411011
Country
India

12. IPD Sharing Statement

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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

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