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Immunosuppressant
Fingolimod for Kidney Transplant Rejection
Phase 2
Waitlist Available
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receiving a first or second kidney transplant
Able to take oral medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months after kidney transplant, 1 year after kidney transplant
Awards & highlights
Study Summary
This trial is testing if a drug called fingolimod can help prevent kidney transplant failure. The study is double-blind, meaning neither the patients nor the doctors will know who is receiving the real drug or the fake drug (placebo).
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Fingolimod may cause side effects like slow heart rate, increased risk of infections due to its immune system effects, potential liver problems, and possibly vision issues such as macular degeneration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am getting my first or second kidney transplant.
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I can take medicine by mouth.
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I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months after kidney transplant, 1 year after kidney transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months after kidney transplant, 1 year after kidney transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Emergent and Adverse Events
Secondary outcome measures
BMP-7 Protein Biomarker
Biopsy-Proven Acute Rejection
Causes of End-Stage Renal Disease
+10 moreTrial Design
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.
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
271 Previous Clinical Trials
80,355 Total Patients Enrolled
2 Trials studying Kidney Failure
369 Patients Enrolled for Kidney Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am getting my first or second kidney transplant.I have severe liver disease with high liver enzyme or bilirubin levels.I have had cancer before, but it was not skin cancer removed over two years ago.I have been diagnosed with macular degeneration.I am allergic to Gilenya® or its ingredients like fingolimod.I have been diagnosed with a chronic immune system disease.I have not had a fever or infection in the last two weeks.I have not had a stroke in the last 6 months.I agree not to eat grapefruit or drink its juice and to stop blood thinners one week before and after a kidney biopsy.Your body's antibodies are less than 50%.I am a woman who can have children and have a negative pregnancy test.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.Your heart beats less than 60 times per minute.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.Your heart's electrical activity (measured by an ECG) is too slow.You have a heart pacemaker.I agree to use two forms of birth control during and 6 weeks after the study.I can take medicine by mouth.Women who could become pregnant must have a negative pregnancy test before starting treatment.I am between 18 and 65 years old.I am a woman who can have children and agree to use two forms of birth control during and 6 weeks after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Fingolimod
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots in the trial for participants?
"The clinicaltrials.gov registry shows that this medical trial, having initially been posted on April 15th 2022 and last modified on March 8 2022, is not presently seeking participants. Although the study has ended recruitment, there are still 996 other active trials in need of volunteers."
Answered by AI
Is Fingolimod a viable therapeutic option with minimal risks?
"After careful consideration, our team at Power gave Fingolimod a rating of 2 on the safety scale. This is due to Phase 2 trial results that show some evidence of its safety but not yet any indication of efficacy."
Answered by AI
Does this examination accept participants who are of legal age or older?
"This medical research project seeks to include participants within the age range of 18 and 65."
Answered by AI
Is there a specific target demographic for enrollment in this research project?
"This clinical study seeks 20 participants who suffer from chronic kidney failure and are between 18-65 years of age. The following criteria must also be met: consent form signed and dated, recipients of either a first or second kidney transplant, male/female gender, pregnancy test negative in female patients capable of bearing children, two forms of effective contraceptive used during the trial period plus six weeks after its completion or final dose taken (barrier method included), antibodies <50% reactive, ability to take oral medication consistently throughout duration of study with adherence to lifestyle considerations such as no grapefruit intake and discontinuation one week before and post biopsy procedure for ant"
Answered by AI
Who else is applying?
What state do they live in?
Iowa
How old are they?
18 - 65
What site did they apply to?
Houston Methodist Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Most responsive sites:
- Houston Methodist Research Institute: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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