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

Anemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321919
• Other study ID #: BA16169
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2006
• Last updated: October 28, 2015
• Start date: July 2000
• Est. completion date: April 2005

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: April 2005
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• epoetin beta [NeoRecormon]
Patients in the early treatment group immediately started epoetin\nbeta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase.
• epoetin beta [NeoRecormon]
Patients in the late treatment Group started epoetin beta treatment once a decline in Hb level to <10.5 g/dL had occurred.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Ireland,  Italy,  Mexico,  Norway,  Poland,  Portugal,  Russian Federation,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Combined endpoint of all major cardiovascular events (time to first event)		Every three months up to four years	No
Secondary	Time to event and frequency of episodes for: cardiovascular mortality, all cause mortality, chronic heart failure (NYHA classification), cardiovascular interventions		Every three months up to four years	No
Secondary	Number of hospital admissions for cardiovascular reasons		Every three months up to four years	No
Secondary	Duration of hospitalizations for cardiovascular reasons		Every three months up to four years	No
Secondary	Effect of early epoetin beta treatment on left ventricular mass index		Every three months up to four years	No
Secondary	Effect of early epoetin beta treatment on left ventricular volume		Every three months up to four years	No
Secondary	Effect of early epoetin beta treatment on left\nventricular ejection fraction		Every three months up to four years	No
Secondary	Effect of early epoetin beta treatment on fractional myocardial shortening		Every three months up to four years	No
Secondary	Effect of early epoetin beta treatment on Quality of Life (SF-36 questionnaire)		Every three months up to four years	No