Trial information
A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia
Status: Completed
Protocol number: BA16169
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of NeoRecormon on reduction of cardiovascular risk in patients with chronic renal anemia who are not on renal replacement therapy.
Brief summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals. Target sample size is
630.
Study phase: III
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: Combined endpoint of all major cardiovascular events
Key secondary outcomes: 1. Efficacy: All-cardiovascular and all-cause mortality, chronic heart failure, cardiovascular intervention, hospital admissions, cardiac structure and function by ECHO cardiography, QOL. Safety: BP/antihypertension medication, AEs, lab tests.
Inclusion criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- not receiving renal replacement therapy.
Exclusion criteria:
- women who are pregnant or lactating;
- previous treatment with erythropoietin or other erythropoietic substance;
- blood transfusion within the last 3 months;
- need for dialysis expected in the next 6 months;
- administration of another investigational drug within 30 days preceding study start, or during the study.
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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Austria
Belgium
China
Czech Republic
- Brno
- Havirov
- Olomouc
- Ostrava
Denmark
- Fredericia
- Herlev
- Holbaek
- Roskilde
Finland
France
- Amiens
- Angouleme
- Bordeaux
- Boulogne
- Colmar
- Limoges
- Lyon
- Montpellier
- Paris
- Saint Brieuc
- Strasbourg
- Troyes
- Vandoeuvre-Les-Nancy
Germany
- Berlin
- Giessen
- Villingen-Schwenningen
- Würzburg
Greece
- Athens
- Thessaloniki
- Veria
Ireland
Italy
- Bologna
- Busto Arsizio
- Cagliari
- Cinisello Balsamo
- Lecco
- Napoli
- Padova
- Parma
- Pavia
- Piacenza
- Roma
- San Giovanni Rotondo
- Sondrio
- Trieste
- Vimercate
Mexico
Norway
Poland
- Gdansk
- Kielce
- Krakow
- Wroclaw
Portugal
- Almada
- Carnaxide
- Lisboa
- Porto
Russian Federation
Spain
- Barcelona
- Las Palmas de Gran Canaria
- Madrid
- Valencia
Sweden
- Boras
- Helsingborg
- Huddinge
- Jonkoping
- Karlstad
- Oerebro
- Stockholm
- Sundsvall
Taiwan
- Taichung
- Tainan
- Taipei
- Taoyuan
Thailand
United Kingdom
- Belfast
- Carshalton
- London
- Newcastle upon Tyne
- Salford
- Southampton
