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NCT Number: NCT00642668

A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

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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

ASZ Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult participants, >=18 years of age;
  • Chronic renal anemia;
  • No ESA therapy during previous 3 months.

Exclusion criteria

  • Transfusion of red blood cells during previous 2 months;
  • Poorly controlled hypertension requiring hospitalization in previous 6 months;
  • Significant acute or chronic bleeding.

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)

Other names: Mircera

Primary outcomes

  1. Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range

    Time frame: Weeks 29-36

    The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.

Secondary outcomes

  1. Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)

    Time frame: Weeks 0-36

    The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.

  2. Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)

    Time frame: Weeks 29-36

  3. Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)

    Time frame: Weeks 29-36

  4. Percentage of Participants With Adverse Events

    Time frame: Weeks 1-40

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Subcutaneous Treatment of Anemia in Patients With a GFR Below 45 ml/Min/1.73m2 Through Injections With Mircera as Low Frequent as Once Monthly (STABILO)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2008
Registry last updated
Jul 5, 2017

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

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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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