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Completed

NCT Number: NCT00642967

A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.

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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 3

Primary location

Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
  • continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.

Exclusion criteria

  • transfusion of red blood cells during previous 2 months;
  • significant acute or chronic bleeding;
  • poorly controlled hypertension.

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.

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

Primary outcomes

  1. Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period

    Time frame: Weeks 16-24

Secondary outcomes

  1. Mean change in Hb concentration

    Time frame: Between reference and Efficacy Evaluation Period

  2. Mean time spent in Hb range

    Time frame: Weeks 16-24

  3. % patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions

    Time frame: Weeks 16-48

  4. AEs, lab parameters

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 25, 2008
Registry last updated
Sep 14, 2021

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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