Trial information
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
Status: Completed
Protocol number: MA16620
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of anemia correction with NeoRecormon on cardiac structure and function in anemic patients with early diabetic nephropathy.
Brief summary: This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals. Target sample size is 160.
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: Left ventricular mass index
Key secondary outcomes: 1. Efficacy: LVESVI, LVEDVI, left ventricular ejection fraction, fractional shortening, % patients with stable hemoglobin levels between 13-15 g/dL. Safety: Adverse events, lab parameters, vital signs.
Inclusion criteria:
- adult patients >=18 years of age;
- type 1 or type 2 diabetes;
- stable glycemic control for >=3 months;
- diabetic nephropathy.
Exclusion criteria:
- women who are pregnant, breastfeeding, or unwilling to use a reliable contraceptive method;
- previous treatment with erythropoietin or other erythropoietic substance;
- nondiabetic renal disease, nephrotic syndrome;
- blood transfusion within the 3 months prior to enrollment;
- administration of any investigational drug within 30 days preceding the study start, and 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: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Austria
Brazil
Czech Republic
Denmark
Finland
Germany
Greece
- Alexandroupolis
- Athens
- Ioannina
- Nikea
- Thessaloniki
- Veria
Hungary
- Budapest
- Miskolc
- Pecs
- Szombathely
Italy
- Ancona
- Cagliari
- Caserta
- Cinisello Balsamo
- Desio
- Lecco
- Messina
- Milano
Mexico
- Chihuahua
- Mexico City
- Monterrey
Poland
Russian Federation
Singapore
Spain
- Barakaldo
- Barcelona
- Galdakao
- La Coruna
- Madrid
- Valencia
Sweden
Thailand
- Bangkok
- Chiang Mai
- Chonburi
United Kingdom
- Belfast
- Cambridge
- London
- Middlesborough
- Salford
- Sheffield
- Wrexham
