NCT05285878 is a Phase 2 clinical trial of Fingolimod in Interstitial Fibrosis, sponsored by The Methodist Hospital Research Institute.

Who is sponsoring NCT05285878?

NCT05285878 is sponsored by The Methodist Hospital Research Institute.

What drugs are being tested in NCT05285878?

Interventions in NCT05285878: Fingolimod, Placebo.

What condition does NCT05285878 study?

NCT05285878 studies Interstitial Fibrosis, Kidney Transplant; Complications, Kidney Transplant Rejection, Kidney Transplant Failure and Rejection, Kidney Transplant Failure, Kidney Failure, Chronic, Graft Rejection.

Is NCT05285878 still recruiting?

NCT05285878 is currently enrolling by invitation. Last updated 12 March 2025.

Last reviewed 2025-03-12 · How we verify

NCT05285878

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

ENROLLING BY INVITATION Phase 2 Last updated 12 March 2025

What this trial tests

Phase 2 trial testing Fingolimod in Interstitial Fibrosis in 20 participants. Enrolling by invitation.

Timeline

28 July 2022

Primary endpoint
1 June 2027

1 December 2027

Quick facts

Lead sponsor	The Methodist Hospital Research Institute
Phase	Phase 2
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	28 July 2022
Primary completion	1 June 2027
Estimated completion	1 December 2027
Sites	1 location across United States

Drugs / interventions tested

Fingolimod (FINGOLIMOD) — full drug profile →
Placebo

Conditions studied

Interstitial Fibrosis — all drugs for Interstitial Fibrosis →
Kidney Transplant; Complications — all drugs for Kidney Transplant; Complications →
Kidney Transplant Rejection — all drugs for Kidney Transplant Rejection →
Kidney Transplant Failure and Rejection — all drugs for Kidney Transplant Failure and Rejection →

Sponsor

The Methodist Hospital Research Institute

Who can join

Adults 18 to 65, any sex, with Interstitial Fibrosis or Kidney Transplant; Complications. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Emergent and Adverse Events
Time frame: Baseline (day of kidney transplant surgery); 3, 14, 30, 90, 180, 270, and 365 days after starting study drug or placebo
The difference in the proportion of cumulative treatment-emergent (TE) adverse events (AE) determined to be ≥ grade 3 severity that occur during 12 months from the first dose of FTY720 compared to the placebo group.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Fingolimod

Trials testing the same drug.

NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis · Phase 2, PHASE3 · not yet recruiting
NCT06408259 — Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relap · Phase 3 · recruiting
NCT06087965 — Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage · Phase 1, PHASE2 · unknown
NCT05123703 — A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Re · Phase 3 · active not recruiting

Other The Methodist Hospital Research Institute trials

Trials by the same sponsor.

NCT07048314 — Stem Cells for Erectile Dysfunction Post RALP · Phase 1, PHASE2 · not yet recruiting
NCT07283068 — IO Vancomycin Into the Medial Malleolus vs IV Administration in Revision TKA · NA · not yet recruiting
NCT07218484 — VoiceLove Digital Therapy for Delirium in the ICU · NA · recruiting
NCT07050771 — Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery · Phase 2 · recruiting
NCT07182279 — Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05285878 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Methodist Hospital Research Institute
Last refreshed: 12 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05285878.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing