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

This study has been terminated.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00440063
First received: February 23, 2007
Last updated: December 18, 2007
Last verified: December 2007

February 23, 2007
December 18, 2007
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Percentage of patients achieving target Hb within 20 weeks.
Same as current
Complete list of historical versions of study NCT00440063 on ClinicalTrials.gov Archive Site
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.
Same as current
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A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.
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

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Drug: epoetin beta [NeoRecormon]
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00440063
ML20828
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Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP