Trial information
A Study of NeoRecormon in Patients With Chronic Kidney Disease.
Status: No longer recruiting
Protocol number: ML20200
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to investigate the effect of NeoRecormon on hemoglobin level and renal function in patients with chronic kidney disease, stage 2-4
Brief summary: This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
90.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta [NeoRecormon]
Primary outcome: 1. Hb level, decline in renal function, 24h proteinuria, creatinine clearance. Time frame: Throughout study
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, not on dialysis;
- Hb <110g/L.
Exclusion criteria:
- unstable hypertension;
- acute infections;
- use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
- myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.
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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Serbia and Montenegro
