drugset / Trial / NCT00817687

A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation

NCT00817687

Phase 4 Completed 66 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2009-01
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mycophenolate Mofetil Small molecule

Indications

No indication recorded.