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

Enrolling by invitation · Phase 2 · Has a placebo group

Conditions studied: Interstitial Fibrosis, Kidney Transplant; Complications, Kidney Transplant Rejection, Kidney Transplant Failure and Rejection, Kidney Transplant Failure, Kidney Failure, Chronic, Graft Rejection

In brief

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.

Key facts

Study ID: NCT05285878
Run by: The Methodist Hospital Research Institute
People needed: 20
Starts: 2022-07-28
Expected to finish: 2027-12-01
Last updated by the study team: 2025-03-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Receiving a first or second kidney transplant
Male or female, aged ≥18 to ≤65
Women of child bearing potential who have a negative serum pregnancy test prior to treatment
Women of child bearing potential (including perimenopausal women who have had a menstrual period within the previous 1 year) who agree to use 2 forms of effective birth control regimen (at least one of which is a barrier method) throughout the study period and for 6 weeks following the end of the study or the last dose of mycophenolic acid, whichever comes first.
Panel of reactive antibodies <50%
Able to take oral medication
Agreement to adhere to Lifestyle Considerations throughout study duration: refraining from the consumption of grapefruit or grapefruit juice and stopping any anticoagulation therapy, including ASA, one week prior and one week post kidney biopsy procedure

You may not qualify if…

Transplantation of any organ other than kidney
History or presence of second degree AV block, third degree AV block, symptomatic bradycardia, or an arrhythmia requiring current treatment with Class Ia or III antiarrhythmic drugs.
Heart rate <60 beats per minute
Presence of an increased QTc interval > 500 ms on screening ECG.
Presence of a cardiac pacemaker.
History of any major cardiac events, including heart attack within the last six months of enrollment, unstable angina, congestive heart failure, or any severe cardiac disease as determined by investigator
Known macular degeneration
Diagnosed with any significant coagulopathy or medical condition requiring long-term systemic anticoagulation after transplantation, which would interfere with obtaining biopies.
Diagnosed with chronic immune system disease
Diagnosed with acute pulmonary disease
Diagnosed with severe liver disease, including abnormal liver enzymes or total bilirubin greater than three times upper limit of normal.
Diagnosed with any past or present malignancies except squamous or basal cell carcinoma of the skin excised at least two years prior to randomization.
Diagnosed with active acute or chronic infection, or febrile illness within two weeks prior to randomization.
Recent history of strokes in the preceding 6 months
Use of ketoconazole for more than 2 weeks
Use of any investigational drug during the 4 weeks prior to enrolling in this study
Women of child bearing potential who are breastfeeding
Women of childbearing potential not practicing reliable methods of contraception. Reliable methods for contraception include surgical sterilization (hysterectomy, bilateral tubal ligation), double-barrier method (such as condom and diaphragm). To be considered as post-menopausal and not of childbearing potential, female participants must have experienced 12 consecutive months of amenorrhea.
Known allergic reactions to components of Gilenya®, specifically fingolimod, gelatin, magnesium stearate, mannitol, titanium dioxide, and/or yellow iron oxide
Presence of any medical or psychosocial condition, which the investigator believes, would hinder adherence to the study requirements.

Where it is running

Houston Methodist Research Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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