Prospective Donor Specific T Response Measurment for IS Minimization in de Novo Renal Transplantation
Status:
Completed
Trial end date:
2020-10-31
Target enrollment:
Participant gender:
Summary
The main objective of the study is to demonstrate the utility and safety of the IFN-γ
(Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification
of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The
enrichment study will test non-inferiority of low IS regimen compared to high IS regimen,
assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit
of maximum 10%.