Trial information
CONCEPT study - A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Recipients
Status: No longer recruiting
Protocol number: ML18326
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of CellCept, Zenapax (daclizumab), and corticosteroids, with delayed introduction of sirolimus plus discontinuation of cyclosporine, on renal function in kidney transplant patients
Brief summary: This study will evaluate renal function in kidney transplant patients treated with daily CellCept. All patients will receive CellCept, Zenapax (daclizumab), and corticosteroids. Some patients will receive cyclosporine during the entire study; others will discontinue cyclosporine coupled with initiation of sirolimus. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 208.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Efficacy: Renal function: creatinine clearance assessed at 52 weeks post-transplantation. Safety: Adverse events, 24-hour proteinuria, cancers and lymphoproliferative syndromes, premature discontinuations for adverse events
Key secondary outcomes: 1. Efficacy: Creatininemia; creatinine clearance, patient and graft survival, and acute biopsy-proven or presumed rejections from W12 to W52; glomerular filtration rate at W12 and W52, histologic evaluation of graft at W52
Inclusion criteria:
- adult patients 18-75 years of age;
- receipt of a first cadaveric kidney graft.
Exclusion criteria:
- kidney from a living donor; donor >65 years of age; second renal graft, or more; or multiple organ transplant;
- known hypersensitivity to any of the drugs in the study or their components;
- history of cancer or malignancy during previous 5 years, other than successfully treated spinocellular or basal cell cancer.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: November, 2004
Trial registration date: 08/29/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
France
- Amiens
- Angers
- Caen
- Clermont-Ferrand
- La Tronche
- Lille
- Limoges
- Paris
- Poitiers
- Reims
- Rennes
- Rouen
- Strasbourg
- Tours
