Prospective Donor Specific T Response Measurment for IS Minimization in de Novo Renal Transplantation

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%.

Timeline

Start

2015-03

Primary completion

2020-10

Completion

2020-10-31

Drugs

Indications