NCT05285878
Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
Enrolling by Invitation
PHASE2Ages 18–65InterventionalTreatmentThe Methodist Hospital Research InstituteInvestigator-initiated
~20 participants
Updated 2025-03-14 on ClinicalTrials.gov
What's tested:FingolimodPlacebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Emergent and Adverse Events
Measured over Baseline (day of kidney transplant surgery); 3, 14, 30, 90, 180, 270, and 365 days after starting study drug or placebo
Conditions
Where it's being run
1 sites across 1 statesTexas1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Exclusion
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.
What this trial measures
- Emergent and Adverse EventsBaseline (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.