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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440063
First Posted: February 26, 2007
Last Update Posted: December 20, 2007
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.
Information provided by:
Hoffmann-La Roche
  Purpose
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 Intervention Phase
Anemia Drug: epoetin beta [NeoRecormon] Phase 4

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • 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.

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00440063


Locations
Australia
Adelaide, Australia
Gosford, Australia
Herston, Australia
Liverpool, Australia
Parkville, Australia
Perth, Australia
Sydney, Australia
Tasmania, Australia
Woolloongabba, Australia
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

ClinicalTrials.gov Identifier: NCT00440063     History of Changes
Other Study ID Numbers: ML20828
First Submitted: February 23, 2007
First Posted: February 26, 2007
Last Update Posted: December 20, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics