Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation

This is a randomized, double-blind, placebo-controlled trial in de novo kidney transplant patients to determine if the addition of fingolimod (brand name Gilenya®, candidate name- FTY720) on the background of standard immunosuppression will prevent expansion of the interstitial compartment of the transplanted kidney. Interstitial expansion is the precursor of interstitial fibrosis and graft loss. The study will test the hypothesis that abgrogating the fibrogenic effects of both the RhoA and mTOR pathways with fingolimod will reduce structural damage in transplanted kidneys and possible subsequent transplant failure.

NCT Number	NCT05285878
Lead Sponsor	The Methodist Hospital Research Institute
Conditions	Interstitial Fibrosis, Kidney Transplant; Complications, Kidney Transplant Rejection, Kidney Transplant Failure and Rejection, Kidney Transplant Failure, Kidney Failure, Chronic, Graft Rejection
Enrollment	20 participants
Start Date	2022-07-28
Primary Completion	2027-06 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2025-03-14