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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00321919
First received: May 3, 2006
Last updated: October 17, 2006
Last verified: May 2006
  Purpose

This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.


Condition Intervention Phase
Anemia
Drug: epoetin beta [NeoRecormon]
Phase 3

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, Open-Label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: Combined endpoint of all major cardiovascular events

Secondary Outcome Measures:
  • Efficacy: All-cardiovascular and all-cause mortality, chronic heart failure, cardiovascular intervention, hospital admissions, cardiac structure and function by ECHO cardiography, QOL. Safety: BP/antihypertension medication, AEs, lab tests.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • not receiving renal replacement therapy.

Exclusion Criteria:

  • women who are pregnant or lactating;
  • previous treatment with erythropoietin or other erythropoietic substance;
  • blood transfusion within the last 3 months;
  • need for dialysis expected in the next 6 months;
  • administration of another investigational drug within 30 days preceding study start, or during the study.
  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: NCT00321919

  Show 97 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Principal Investigator: Tilman B Drueke, Prof. unaffliated
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00321919     History of Changes
Other Study ID Numbers: BA16169
Study First Received: May 3, 2006
Last Updated: October 17, 2006
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014