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ENROLLING BY INVITATION
NCT05285878
PHASE2

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

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-07-28

Completion Date

2027-12

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

DRUG

Fingolimod

0.5 mg daily

DRUG

Placebo

0.5 mg daily

Locations (1)

Houston Methodist Research Institute

Houston, Texas, United States