Trial information
A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients With Impaired Renal Function
Status: Completed
Protocol number: M55018
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label, expanded access study of daily CellCept combined with a reduced daily dose of cyclosporine versus a full dose of cyclosporine on evolution of renal function in kidney transplant recipients with impaired renal function
Brief summary: This study will compare the efficacy and safety of daily CellCept combined with a reduced daily dose of cyclosporine versus a full dose of cyclosporine in kidney transplant recipients with impaired renal function. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Target sample size is
102.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Single Group; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Efficacy: Evolution of renal function evaluated by linear regression of the inverse of serum creatinine as a function of time
Key secondary outcomes: 1. Safety: AEs, OIs, malignancies, cardiovascular risk factors
Inclusion criteria:
- adult patients 18-65 years of age;
- kidney transplant 1-10 years ago;
- treatment with a cyclosporine-based immunosuppressant regimen for >=3 months.
Exclusion criteria:
- treatment with CellCept or Prograf during last 3 months;
- an acute rejection treated during last 3 months;
- history of cancer or malignancy, other than successfully treated spinocellular or basal cell cancers.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 08/25/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
France
- Besancon
- Brest
- Creteil
- Le Kremlin-Bicetre
- Lille
- Nice
- Paris
- Pierre Benite
- Strasbourg
- Toulouse
- Vandoeuvre-Les-Nancy
