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

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: epoetin beta [NeoRecormon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00413101

ML20201

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

1

Experimental group

Treatment:

Drug: epoetin beta [NeoRecormon]