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OpenTrials
Completed

NCT Number: NCT00077597

A Study of Mircera for the Treatment of Anemia in Dialysis Patients

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years 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

Curitiba, Brazil

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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 patients >=18 years of age;
  • chronic renal anemia;
  • dialysis therapy for at least 2 weeks before screening.

Exclusion criteria

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

Treatment and study plan

Epoetin

Drug

3 times a week iv, as prescribed.

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

0.4 micrograms/kg iv (starting dose) once every 2 weeks

Primary outcomes

  1. Hemoglobin response rate

    Time frame: Weeks 1-24

Secondary outcomes

  1. Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n

    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 Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 12, 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.

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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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