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Completed

NCT Number: NCT00081484

A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. 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

Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • on dialysis therapy for at least 12 weeks before screening;
  • receiving iv or sc epoetin for at least 8 weeks before screening.

Exclusion criteria

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of another investigational drug within 4 weeks before screening, or during the study period.

Treatment and study plan

epoetin alfa or beta

Drug

iv or sc, as prescribed

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks

Primary outcomes

  1. Change in hemoglobin concentration

    Time frame: Weeks 1-36

Secondary outcomes

  1. Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration

    Time frame: Weeks 29-36

  2. RBC transfusions

    Time frame: Weeks 1-36

  3. AEs, laboratory parameters, vital signs

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 16, 2004
Registry last updated
Nov 2, 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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