One-year Exploratory Study to Evaluate the Safety of Partial Replacement of CNI With Chronic Administration of Simulect in de Novo Normal-risk Kidney Transplant Recipients Treated With MPA
The use of CNI's after kidney transplantation is associated with typical adverse effects
such as potential contribution to progressive impairment of renal function, hypertension,
and metabolic abnormalities. The study consists of a run-in phase (1 month),and treatment
phase (11 months) and safety assessment phase (1 month).
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the risk of sensitization against the chimeric antibody, Simulect.
Mysore Anil S. Kumar, MD
Drexel University College of Medicine
United States: Institutional Review Board
|Drexel University College of Medicine||Philadelphia, Pennsylvania 19129|