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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00440063     History of Changes
Other Study ID Numbers: ML20828
Study First Received: February 23, 2007
Last Updated: December 18, 2007
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014