Trial Information

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

Status: Completed

Protocol Number: BA16169

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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.

Brief Summary: 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. Target sample size is 630.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Anemia

Intervention Type: Drug

Intervention Name: epoetin beta [NeoRecormon]

Primary Outcome: 1. Efficacy: Combined endpoint of all major cardiovascular events

Key Secondary Outcomes: 1. 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.

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.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Linz, Austria, 4020
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 7, 2008 at 2:35:27 PM


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