A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440063
Recruitment Status : Terminated
First Posted : February 26, 2007
Last Update Posted : December 20, 2007
Information provided by:
Hoffmann-La Roche

Brief Summary:
This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.

Condition or disease Intervention/treatment Phase
Anemia Drug: epoetin beta [NeoRecormon] Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study to Compare the Safety and Effectiveness of Two Monitoring Schedules to Maintain Hemoglobin Levels and Iron Parameters in Patients With Renal Anemia Receiving NeoRecormon

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Primary Outcome Measures :
  1. Percentage of patients achieving target Hb within 20 weeks.

Secondary Outcome Measures :
  1. Efficacy: % of patients exceeding upper Hb target; % who fail to reach target Hb; median time to achieve Hb target; dose of NeoRecormon required to meet target Hb concentration; % who maintain target iron parameters. Safety: AEs, SAEs.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-80 years of age;
  • stage 3-4 chronic kidney disease (eGFR 15-60mL/min);
  • Hb <100g/L, TSAT>=20%, and ferritin >=100 mcg/L at screening.

Exclusion Criteria:

  • anticipating to go on renal replacement therapy;
  • anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant;
  • uncontrolled hypertension;
  • congestive heart failure;
  • active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00440063

Adelaide, Australia
Gosford, Australia
Herston, Australia
Liverpool, Australia
Parkville, Australia
Perth, Australia
Sydney, Australia
Tasmania, Australia
Woolloongabba, Australia
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche Identifier: NCT00440063     History of Changes
Other Study ID Numbers: ML20828
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: December 20, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Hematologic Diseases
Epoetin Alfa