NCT01191983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_4

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

7.7 years

First QC Date

August 16, 2010

Last Update Submit

July 17, 2018

Conditions

Anemia

Outcome Measures

Primary Outcomes (3)

  • Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)

    EEP (Week 17 up to Week 24)

  • Change in Hb Concentration Between Baseline and EEP

    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

    EEP: (Week 17 up to Week 24)

Secondary Outcomes (4)

  • Percentage of Participants With Adverse Events

    Baseline (Week -2 up to Week 0) to Week 28

  • Percentage of Participants With Red Blood Cell Transfusion During Treatment Period

    Week 0 up to Week 24

  • Percentage of Participants with anti-epoetin antibodies

    Baseline (Week-2 up to Week 0) up to Week 28

  • Short Form-36 Health Survey (SF-36) score

    Week 0 to Week 24

Study Arms (1)

Methoxy polyethylene glycol-epoetin beta

EXPERIMENTAL

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]

Interventions

Methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W

Also known as: Mircera, C.E.R.A
Methoxy polyethylene glycol-epoetin beta

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Osmania General Hospital; Department of Nephrology

Hyderabad, Andhra Pradesh, 500012, India

Location

Pushpawati Singhania Research Institute; Nephrology

New Delhi, National Capital Territory of Delhi, 110017, India

Location

Indraprastha Apollo Hospitals

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Vijayratna Diabetes Diagnosis & Treatment Center

Ahmedabad, 380007, India

Location

M S Ramaiah Memorial Hospital

Bangalore, 560054, India

Location

North Delhi Diabetes Centre

Delhi, 110085, India

Location

MAX Balaji Hospital

Delhi, 110092, India

Location

Dr.Modi's Clinic

Hyderabad, 500001, India

Location

IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre

Kolkata, 700 020, India

Location

Apex Kidney Care Pvt. Ltd., Sushrut Hospital

Mumbai, 400 071, India

Location

Diab Care Centre

Mumbai, 400076, India

Location

Sanjeevani Hospital

Mumbai, 400097, India

Location

Sahyadri Speciality Hospital

Pune, 411004, India

Location

Diabetes Care & Research Centre

Pune, 411011, India

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 31, 2010

Study Start

August 13, 2010

Primary Completion

April 23, 2018

Study Completion

April 23, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

IN(14)