Trial information
A Study of Different Methods of Administration of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia
Status: Completed
Protocol number: ML18217
Sponsor: Roche Polska Sp z o.o.
Company division: Pharmaceutical
Official Scientific Title: A randomized, cross-over, open-label study of the cost-effectiveness of NeoRecormon administrated subcutaneously or intravenously in dialysis patients with renal anemia
Brief summary: This study will evaluate the safety and cost-effectiveness of NeoRecormon in patients with renal anemia who are on dialysis. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
98.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Crossover; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Efficacy: To compare cost-effectiveness of NeoRecormon by the intravenous versus subcutaneous route on normalization of Hb to within 10-12 g/dL.
Key secondary outcomes: 1. Safety: Adverse events; clinical laboratory tests; iron balance parameters and blood pressure.
Inclusion criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- regular, stable dialysis for >=3 months.
Exclusion criteria:
- hemoglobinopathy (ie, sickle cell disease, thalassemia);
- gastrointestinal bleeding requiring medication or transfusion;
- hypertension causing interruption of epoetin treatment;
- malignant disease (except skin cancer requiring local treatment only);
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/28/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Poland
- Bialystok
- Bydgoszcz
- Gdansk
- Grodzisk Mazowiecki
- Krosno
- Oswiecim
- Poznan
- Rzeszow
- Warszawa
- Wroclaw
