Trial information
A Study of NeoRecormon (Epoetin Beta) in Predialysis Patients With Renal Anemia
Status: Completed
Protocol number: ML18101
Sponsor: Roche Bulgaria EOOD
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the tolerability and flexibility of multi-dose NeoRecormon administered by Reco-Pen in pre-dialysis patients with chronic renal anemia.
Brief summary: This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by Reco-Pen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 60.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Percent of patients who change to once weekly NeoRecormon; percent of patients who change dose during treatment. Adverse events:patients with local intolerability (pain, allergic reactions); patients withdrawal due to inability to use the RecoPen
Key secondary outcomes: 1. Quality of life evaluated by the Short Form 36
Inclusion criteria:
- adult patients 18-65 years of age;
- chronic renal failure (Stages I-III);
- no previous epoetin therapy.
Exclusion criteria:
- poorly controlled hypertension;
- history or evidence of malignancy;
- relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug;
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 10/28/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
