A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant
- adult patients, >=18 years of age;
- in receipt of an initial cadaveric kidney transplant;
- in receipt of graft with biopsy;
- in receipt of a 'marginal' kidney transplant.
- in receipt of a second kidney transplant;
- in receipt of a multi-organ transplant or a double kidney transplant;
- malignant tumor, or a history of cancer in past 5 years, other than successfully
treated basal cell or spinocellular cancer or cancer in situ of cervix;
- replicating hepatitis B and/or C, or HIV positive serology.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with >=25% increase in fibrosis score
Outcome Time Frame:
Day 0 to Week 52