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Completed

NCT Number: NCT00642850

STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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 3

Primary location

Brno, Czechia

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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 renal anemia;
  • Continuous stable intravenous maintenance epoetin therapy during previous month;
  • Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion criteria

  • Transfusion of red blood cells during previous 2 months;
  • Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
  • Significant acute or chronic bleeding.

Treatment and study plan

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

120, 200 or 360 micrograms iv monthly (starting dose)

Primary outcomes

  1. Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range

    Time frame: Week 17 up to Week 24

    Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.

Secondary outcomes

  1. Change in Hemoglobin Concentration Between Reference (SVP) and EEP

    Time frame: Week -4 up to Week -1 and Week 17 up to Week 24

    The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.

  2. Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP

    Time frame: Week 17 up to Week 24

    Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.

  3. Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

    Time frame: Week 17 up to Week 24

    Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.

  4. Percentage of Participants Requiring Any Dose Adjustment

    Time frame: Week 1 to Week 16 and Week 17 to Week 24

    Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.

  5. Number of Participants With Red Blood Cell Transfusion During the Study

    Time frame: Week -4 up to Week 28

    Number of participant who underwent red blood cell transfusion during the study was reported.

  6. Number of Participants With Anti-epoetin Antibody

    Time frame: Week -4 and at early withdrawal or Week 28

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2008
Registry last updated
Jun 23, 2016

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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