Fingolimod for Kidney Transplant Rejection

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The Methodist Hospital Research Institute

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests if fingolimod can help new kidney transplant patients by preventing kidney damage and improving transplant success. Fingolimod works by blocking harmful pathways in the body. The study aims to see if this treatment is safe and effective over time. Fingolimod has been used in multiple sclerosis treatment and is known for its immunomodulating effects, but it has significant potential side effects.

Eligibility Criteria

Adults aged 18-65 who are receiving their first or second kidney transplant can join this trial. They must be able to take oral medication, have a low level of antibodies, and agree to use two forms of birth control if applicable. People with heart issues, severe liver disease, recent strokes, certain infections or cancers (except some skin cancers), or those on anticoagulants cannot participate.

Inclusion Criteria

I am getting my first or second kidney transplant.

I can take medicine by mouth.

I am between 18 and 65 years old.

Exclusion Criteria

I have severe liver disease with high liver enzyme or bilirubin levels.

I have been diagnosed with macular degeneration.

I am allergic to Gilenya® or its ingredients like fingolimod.

I have been taking ketoconazole for more than 2 weeks.

I am a woman able to have children and am currently breastfeeding.

I have a blood clotting disorder or need long-term blood thinners that would make biopsies difficult.

I have a serious heart rhythm problem or take specific heart rhythm medications.

I have been diagnosed with a sudden lung condition.

I have had an organ transplant, but it was not a kidney.

I haven't had any major heart problems in the last 6 months.

Participant Groups

The trial is testing whether Fingolimod added to standard immunosuppression can prevent damage in transplanted kidneys by stopping fibrosis from developing. Participants will either receive Fingolimod or a placebo without knowing which one they're getting.

2Treatment groups

Active Control

Placebo Group

Group I: FingolimodActive Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Fingolimod is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Gilenya for: