Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
Interstitial Fibrosis, Kidney Transplant; Complications, Kidney Transplant Rejection
About this trial
This is an interventional treatment trial for Interstitial Fibrosis focused on measuring Fingolimod Hydrochloride, Kidney Transplantation, Glomerular Filtration Rate, Kidney, Fibrosis, Immunosuppression Therapy, TOR Serine-Threonine Kinases, Graft Survival, Transplantation, Transplant Recipients, Organ Transplant, Tubular Atrophy, Interstitial Fibrosis and Tubular Atrophy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Houston Methodist Research Institute
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Fingolimod
Participants will take a placebo capsule daily for 3 months. Placebo will be methylcellulose encapsulated into an opaque closed gelatin capsule for blinding. Capsules will be placed in a labeled bottle, with the contents only identifiable by a code on the package label and only the compounding pharmacy and the unblinded pharmacist at Houston Methodist Investigational Drug Service will know the code definition.
Participants will take a 0.5 mg fingolimod capsule each day for 3 months. The fingolimod capsule will be placed inside an opaque closed gelatin capsule without transformation of the manufacteror's fingolimod capsule. The fingolimod blinded product and the placebo capsule will be identical in size, color, appearance, and weight.