This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
As prescribed; + early biopsy
As prescribed; + standard treatment
Unnamed facility
Besançon, France
Unnamed facility
Bordeaux, France
Unnamed facility
Caen, France
Proportion of patients with >=25% increase in fibrosis score
Time frame: Day 0 to Week 52
Renal function (creatinine clearance)
Time frame: From randomization to Week 52
Incidence and time of occurrence of clinical acute rejection
Time frame: From randomization to Week 52
Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes
Time frame: Throughout study
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Unnamed facility
Clermont-Ferrand, France
Unnamed facility
Lille, France
Unnamed facility
Limoges, France
Unnamed facility
Marseille, France
Unnamed facility
Nantes, France
Unnamed facility
Paris, France
Unnamed facility
Paris, France
...and 7 more locations