Trial information
A Study of NeoRecormon (Epoetin Beta) in the Treatment of Patients on Hemodialysis
Status: Completed
Protocol number: MA17502
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of NeoRecormon on haemoglobin level/correction in hemodialysis patients.
Brief summary: This study will assess the efficacy of subcutaneous injections of NeoRecormon in hemodialysis patients. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals. Target sample size is 242.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Efficacy: Proportion of patients with stable Hb values, mean weekly dose to maintain Hb, Hb variability
Key secondary outcomes: 1. Safety: Adverse events, clinical laboratory tests, vital signs.
Inclusion criteria:
- adult patients >18 years of age;
- stable on hemodialysis;
- renal anemia treated with intravenous darbepoetin alfa once weekly for >=12 weeks prior to study enrollment.
Exclusion criteria:
- women who are pregnant or breastfeeding;
- severe concomitant chronic disease (eg, chronic heart failure) or active malignant disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
- Mons
- Roeselare
- Verviers
- Zottegem
France
- Le Raincy
- Lyon
- Quimper
- Reims
- Saint Brieuc
- St Priest En Jarez
- Strasbourg
Germany
- Ansbach
- Bamberg
- Cottbus
- Dessau
- Dortmund
- Düsseldorf
- Giessen
- Hoyerswerda
- Karlsruhe
- Kiel
- Leipzig
- Minden
- Solingen
- Weiden
- Weinheim
Greece
- Athens
- Piraeus
- Thessaloniki
- Veria
Italy
- Arenzano
- Palermo
- Pavia
- Rimini
Portugal
Sweden
