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Completed

NCT Number: NCT00081471

A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not 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

Clayton, Australia

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 kidney disease;
  • anemia;
  • not on dialysis therapy;
  • not receiving epoetin.

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

darbepoetin alfa

Drug

0.45 micrograms/kg sc (starting dose) weekly

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

0.6 micrograms/kg sc (starting dose) once every 2 weeks

Primary outcomes

  1. Hemoglobin response rate

    Time frame: Weeks 1-28

Secondary outcomes

  1. Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\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 Subcutaneous Mircera on Hemoglobin Level/Correction in Non-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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