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Cannabinoid

Cannabidiol + Tacrolimus for Transplant Rejection

Phase 1
Recruiting
Led By Michael Eadon, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a GFR above 60 ml/min/1.73m2 with proteinuria less than 0.3 grams by urine protein to creatinine ratio or 24 hour urine collection (for Healthy volunteer study)
Have a GFR between 16 ml/min and 60 ml/min/1.73m2 or the presence of greater than 0.3 grams of proteinuria by urine protein to creatinine ratio or 24 hour urine collection, but less than 3.5 gm of nephrotic range proteinuria as hypoalbuminemia may impact protein binding (for CKD study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 days
Awards & highlights

Study Summary

This trialaims to find the best dose of drugs to help transplant patients have a better recovery and long-term health.

Who is the study for?
This trial is for adults aged 18-65 with either healthy kidneys or chronic kidney disease, not on dialysis. Participants must avoid certain medications, supplements, and substances like tobacco and marijuana that affect the study drugs' metabolism for two weeks before and during the study. Pregnant or breastfeeding individuals, those with compromised liver function, a history of drug abuse or intolerance to study drugs are excluded.Check my eligibility
What is being tested?
The trial investigates how cannabidiol (Epidiolex) interacts with tacrolimus in people who have received transplants. It aims to find safe dosing levels that could improve health outcomes by studying single doses of each drug alone and together at steady-state conditions.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to Epidiolex; tacrolimus might cause problems such as high blood pressure, shaking hands, kidney problems, headaches, diarrhea, abdominal pain, insomnia or tingling in hands/feet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good and I have low protein in my urine.
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My kidney function is reduced but not severely, and I have a moderate amount of protein in my urine.
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I have been deemed healthy enough to join based on my medical history, blood and urine tests, and EKG results.
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I am between 18 and 65 years old.
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I am willing to dedicate the necessary time for this study.
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I agree not to take any medications or supplements that could affect the study drugs starting 2 weeks before the study.
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I can avoid smoking or using tobacco/marijuana for the study duration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The AUC0-Infinity ratio of tacrolimus with cannabidiol divided by tacrolimus alone
Secondary outcome measures
Immune cell distribution and signaling as measured by scRNA sequencing

Trial Design

4Treatment groups
Active Control
Group I: CYP3A5 expressers without chronic kidney diseaseActive Control3 Interventions
Group II: CYP3A5 non-expressers without chronic kidney diseaseActive Control3 Interventions
Group III: CYP3A5 expressers with chronic kidney diseaseActive Control3 Interventions
Group IV: CYP3A5 non-expressers with chronic kidney diseaseActive Control3 Interventions

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

The National Center for Complementary and Integrative HealthUNKNOWN
Indiana UniversityLead Sponsor
977 Previous Clinical Trials
983,241 Total Patients Enrolled
Michael Eadon, MDPrincipal InvestigatorIndiana University School of Medicine

Media Library

Epidiolex (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05490511 — Phase 1
Cannabidiol Research Study Groups: CYP3A5 expressers without chronic kidney disease, CYP3A5 non-expressers without chronic kidney disease, CYP3A5 expressers with chronic kidney disease, CYP3A5 non-expressers with chronic kidney disease
Cannabidiol Clinical Trial 2023: Epidiolex Highlights & Side Effects. Trial Name: NCT05490511 — Phase 1
Epidiolex (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05490511 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study accept participants aged 40 and older?

"Participants must be of mature age (18+) and not beyond their 65th year to qualify for inclusion in this research."

Answered by AI

Are there any open slots left for participants in the medical experiment?

"Clinicaltrials.gov's records show that this medical investigation is actively enrolling individuals, with the trial first appearing on October 31st 2022 and last modified on January 10th 2023."

Answered by AI

Are CYP3A5 expressers with chronic kidney disease permitted to use this medication according to the FDA?

"Our Power team has assessed the safety of CYP3A5 expressers with chronic kidney disease to be a 1, since this trial is in its initial Phase 1 stage and only preliminary data suggests an efficacy profile."

Answered by AI

What qualifications must participants possess to be eligible for this medical experiment?

"This clinical trial seeks to recruit 72 individuals aged 18-65 who are currently taking cannabidiol. Eligible participants must pass a pre-enrollment screening session, which includes medical history and laboratory tests such as blood/urine analysis, EKG testing, etc., abstain from any prescription medications or supplements that may interact with the study drugs for two weeks prior to enrollment and until completion of the study (26 days total), refrain from smoking tobacco or marijuana in that same time period, have an acceptable GFR value above 60ml/min/1.73m2 with proteinuria below 0.3g OR if they"

Answered by AI
~48 spots leftby Oct 2028