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NCT Number: NCT00773513

A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.

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Key information

Conditions

Chronic Renal Anemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fresenius Medical Care Martinez, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female participants with symptomatic anemia associated with CKD
  • Participants with renal anemia who are not treated with an ESA:
  • Anemia was defined as hemoglobin (Hb) concentration less than (<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment
  • Participants with renal anemia who are on maintenance ESA therapy:
  • If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening
  • Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements)
  • Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent

Exclusion criteria

  • Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy
  • Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD:
  • History of hemoglobinopathy
  • Anemia due to hemolysis
  • Pure red cell aplasia
  • High likelihood of early withdrawal (for example, within 1 year) or interruption of the study
  • Pregnancy or breast-feeding
  • Women of childbearing potential without effective contraception
  • Administration of another investigational drug within 1 month before screening or planned during the study period

Treatment and study plan

darbepoetin alfa

Drug

Darbepoetin alfa will be administered as per approved label.

Other names: Aranesp®, Nespo®, Aranest®

Epoetin alfa

Drug

Epoetin alfa will be administered as per approved label.

Other names: Eprex®, Epogen®, Epopen®, Erypo®

Epoetin beta

Drug

Epoetin beta will be administered as per approved label.

Other names: Neorecormon®, Recormon®

methoxy polyethylene glycol-epoetin beta

Drug

Participants who are currently not being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta administered at a starting dose of 0.6 mcg/kg body weight once every 2 weeks. Participants who are currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta at a dose of 120, 200 or 360 mcg once monthly (based on ESA dose administered in Week -1)

Other names: Mircera®

Primary outcomes

  1. Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First

    Time frame: Baseline up to approximately 8.5 years

Secondary outcomes

  1. Time to All-Cause Mortality

    Time frame: Baseline up to approximately 8.5 years

  2. Time to Non-Fatal and Fatal Myocardial Infarction

    Time frame: Baseline up to approximately 8.5 years

  3. Time to Non-Fatal and Fatal Stroke

    Time frame: Baseline up to approximately 8.5 years

  4. Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)

    Time frame: Baseline up to approximately 8.5 years

  5. Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)

    Time frame: Baseline up to approximately 8.5 years

  6. Percentage of Participants With Gastrointestinal Bleeding

    Time frame: Baseline up to approximately 8.5 years

  7. Percentage of Participants With Thromboembolic Events

    Time frame: Baseline up to approximately 8.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2008
Registry last updated
Aug 20, 2019

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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