A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

Last updated: August 12, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Anemia

Treatment

N/A

Clinical Study ID

NCT00882713
ML21797
  • Ages > 18
  • All Genders

Study Summary

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patients >=18 years of age;

  • chronic renal anemia;

  • regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;

  • continuous iv maintenance epoetin alfa therapy with same dosing interval duringprevious 2 months.

Exclusion

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;

  • poorly controlled hypertension;

  • significant acute or chronic bleeding;

  • active malignant disease (except non-melanoma skin cancer).

Study Design

Total Participants: 202
Study Start date:
February 01, 2009
Estimated Completion Date:
October 31, 2010

Connect with a study center

  • Agadir, 70000
    Morocco

    Site Not Available

  • empty

    Beni Mellal, 23000
    Morocco

    Site Not Available

  • Casablanca, 21000
    Morocco

    Site Not Available

  • empty

    FÉS, 30000
    Morocco

    Site Not Available

  • FÉS, 30000
    Morocco

    Site Not Available

  • Khouribga, 23000
    Morocco

    Site Not Available

  • Marrakech, 40000
    Morocco

    Site Not Available

  • empty

    Méknés, 50300
    Morocco

    Site Not Available

  • Méknés, 50300
    Morocco

    Site Not Available

  • Rabat, 62001
    Morocco

    Site Not Available

  • empty

    Salé, 15045
    Morocco

    Site Not Available

  • Salé, 15045
    Morocco

    Site Not Available

  • Tanger, 90000
    Morocco

    Site Not Available

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