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

Hoffmann-La Roche50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

epoetin beta [NeoRecormon]

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Hb level, BP.

Time frame: Throughout study

LVMI ejection fraction, ejection fraction.

Time frame: 12 months

Secondary Outcomes

SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.