A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• adult patients, 18-75 years of age;

• end-stage renal disease;

• on renal dialysis >= 3 months;

• receiving NeoRecormon treatment >= 3 months;

• Hb stable and <105g/L, and LVMI >160g/m2.

Exclusion Criteria:

• unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;

• use of any ESA other than NeoRecormon;

• acute infection;

• use of iv NeoRecormon.