Trial information
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Status: No longer recruiting
Protocol number: ML19912
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: A randomized study comparing the incidence of acute clinical or subclinical rejection with two dosing regimens of CellCept in de novo renal transplant recipients receiving induction, cyclosporine and brief steroid therapy
Brief summary: This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and early discontinuation of steriods. Patients will be randomized to one of the two treatment arms. Th anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
256.
Study phase: III
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: Number of biopsy-proven acute rejections before week 12, and number of subclinical rejections on systematic biopsy at week 12. Safety: AEs, urinary protein, cancers, discontinuation of immunosuppressants due to AEs.
Key secondary outcomes: 1. Serum creatinine, creatinine clearance, patient and graft survival at week 52, number of acute rejections from week 12 and 52, histological evaluation of graft.
Inclusion criteria:
- adult patients, aged 18-75 years of age;
- in receipt of first donor kidney;
- eligible to receive immunosuppressive treatment comprising IRL2, CellCept, cyclosporine and steroids;
- eligible to receive oral treatment from the first day post-transplantation.
Exclusion criteria:
- patients receiving a second or subsequent kidney transplant, or multi-organ transplant;
- history of malignancy in the last 5 years (except successfully treated squamous cell or basal cell cancer and cervical cancer in situ);
- patients with active hepatitis B and/or hepatitis C, or HIV infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: May, 2006
Trial registration date: 05/04/2006
Date last updated: 11/18/2008
Link to trial result
This trial was conducted at the following locations:
France
- Amiens
- Bordeaux
- Clermont-Ferrand
- Creteil
- Dijon
- La Tronche
- Le Kremlin-Bicetre
- Lille
- Limoges
- Montpellier
- Nice
- Paris
- Poitiers
- Suresnes
- Toulouse
- Tours
- Vandoeuvre-Les-Nancy
