Trial information
A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.
Status: No longer recruiting
Protocol number: ML20201
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to investigate improvement in heart function after complete anemia correction with NeoRecormon in patients with end-stage renal disease already receiving sub-optimal doses of NeoRecormon
Brief 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. Target sample size is 100.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta [NeoRecormon]
Primary outcome: 1. Hb level, BP. Time frame: Throughout study
2. LVMI ejection fraction, ejection fraction. Time frame: 12 months
Key secondary outcomes: 1. SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: August, 2006
Trial registration date: 12/18/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Serbia and Montenegro
