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NCT Number: NCT01191983

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Osmania General Hospital; Department of Nephrology, Hyderabad, Andhra Pradesh, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

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

Other names: Mircera, C.E.R.A

Primary outcomes

  1. 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)

  2. Change in Hb Concentration Between Baseline and EEP

    Time frame: Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24)

  3. 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 outcomes

  1. Percentage of Participants With Adverse Events

    Time frame: Baseline (Week -2 up to Week 0) to Week 28

  2. Percentage of Participants With Red Blood Cell Transfusion During Treatment Period

    Time frame: Week 0 up to Week 24

  3. Percentage of Participants with anti-epoetin antibodies

    Time frame: Baseline (Week-2 up to Week 0) up to Week 28

  4. Short Form-36 Health Survey (SF-36) score

    Time frame: Week 0 to Week 24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2010
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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