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

NCT00321919 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 605

Last updated 2016-06-29

Study results available
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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.

Conditions

Interventions

DRUG

epoetin beta [NeoRecormon]

Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase.

DRUG

epoetin beta [NeoRecormon]

Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to \<10.5 g/dL had occurred.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-31
Primary Completion
2004-10-31
Completion
2004-12-31

Countries

  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Ireland
  • Italy
  • Mexico
  • Norway
  • Poland
  • Portugal
  • Russia
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00321919 on ClinicalTrials.gov