At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 605 enrolled

Drug / intervention

epoetin beta [NeoRecormon] +1 moredrug

Likely dose

epoetin beta [NeoRecormon] 15 gfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00321919

NCT00321919Phase 3Completed

Compare CT.gov

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.

Hoffmann-La Roche·interventional·Posted May 4, 2006·Updated Jun 29, 2016

In Brief

A Phase 3 clinical trial evaluating epoetin beta [NeoRecormon] for Anemia. Completed, enrolled 605 participants across 93 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnemia

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

Collaborators--

Timeline

Phase 3CompletedFinished

2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2000

Primary CompletionOct 2004

Study CompletionDec 2004

First PostedMay 2006

TodayJul 2026

First PostedMay 4, 2006

Enrollment StartJul 1, 2000

Primary CompletionOct 1, 2004

Study CompletionDec 1, 2004

TodayJul 2, 2026

Enrollment to primary: 4.3 yearsPosted 20.2 years ago

Interventions

epoetin beta [NeoRecormon]drug

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.

epoetin beta [NeoRecormon]drug

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