Trial information
NADIR Study: A Study of Neorecormon (Epoetin Beta)in Anemic Patients With Diabetes and Chronic Renal Failure Who Are Not on Dialysis.
Status: Completed
Protocol number: ML18730
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: NADIR study: Multicenter, open-label trial evaluating a simple NeoRecormon treatment regimen in anemic, non-dialysed diabetic patients with chronic renal failure (stages 2 to 5).
Brief summary: This study will evaluate the effect on correction of anemia and quality of life of NeoRecormon in patients with diabetes who have chronic renal failure and are not receiving dialysis. The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals. Target sample size is
450.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Efficacy: Proportion of patients achieving the treatment objective of hemoglobin >11g/dL after the 8-week anemia correction phase. Safety: local injection-site reactions (qualitative evaluation); and recording of adverse events
Key secondary outcomes: 1. Efficacy:(1)% of patients achieving Hb >11g/dL after 4 wk extension phase;(2)% of non-responding patients at wk 8 who achieve Hb >11g/dL at wk 12. Safety: Practicality and safety of auto-administration. Quality of life: SF 36 from baseline to wk 12.
Inclusion criteria:
- adult patients 18-75 years of age;
- type 1 or 2 diabetes;
- chronic renal failure;
- anemia requiring treatment.
Exclusion criteria:
- anemia due to a non-renal cause;
- poorly controlled hypertension;
- previous or current treatment with an ESA (Erythropoiesis Stimulating Agent);
- planned dialysis or organ transplant;
- history of cancer, except for basal cell cancer and cervical cancer in situ.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: October, 2005
Trial registration date: 03/30/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
France
- Aix en Provence
- Annonay
- Arras
- Beauvais
- Blois
- Boulogne
- Bourg En Bresse
- Bourgoin Jallieu
- Cabestany
- Chartres
- Clermont-Ferrand
- Colmar
- Creil
- Creteil
- Evreux
- Greize
- La Tronche
- Lille
- Maubeuge
- Mont-De-Marsan
- Niort
- Orleans
- Paris
- Poissy
- Poitiers
- Quimper
- Reims
- Saint Laurent Du Var
- Saint Lo
- Sens
- Toulouse
- Tournan-En-Brie
- Valence
