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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)
Age 18-65
Must not have
Have history of intolerance, allergic reactions (e.g. rash) or other forms of hypersensitivities to any of the study medications (tacrolimus or cannabidiol)
Are underweight (body mass index (BMI) less than 18.5) or overweight (body mass index (BMI) greater than 35)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand how CBD, a cannabis compound, interacts with tacrolimus, a drug used by organ transplant patients to prevent rejection. Researchers will study these interactions to see if CBD affects the safety and effectiveness of tacrolimus. Tacrolimus is a strong medication used to prevent organ rejection in transplant patients, with precise dosing requirements. The goal is to help doctors adjust doses of both substances to improve patient health and long-term treatment success.
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.
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.
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 belowSelect...
My kidney function is good and I have low protein in my urine.
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I am between 18 and 65 years old.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic or have had bad reactions to tacrolimus or cannabidiol.
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My BMI is either below 18.5 or above 35.
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My kidney function is very low or I am on dialysis.
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My liver tests show bilirubin or enzymes more than twice the normal limit.
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I do not have ongoing stomach issues that affect how I absorb pills.
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I am currently taking medication for sleep or anxiety.
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I am unable to understand and give consent for treatment.
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I have the CYP3A4 *22/*22 genotype.
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I have a history of seizures or currently experience them.
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I am currently taking medication that weakens my immune system.
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I have received an organ or stem cell transplant.
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I was hospitalized unexpectedly at least once in the past 6 months or twice in the past 2 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 27 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The AUC0-Infinity ratio of tacrolimus with cannabidiol divided by tacrolimus alone
Secondary study objectives
Immune cell distribution and signaling as measured by scRNA sequencing
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Tacrolimus is a calcineurin inhibitor that works by suppressing the immune system, specifically by inhibiting T-cell activation, which is essential in preventing organ rejection. Cannabidiol, while not a standard treatment for transplant rejection, has shown anti-inflammatory and immunomodulatory effects that could help in reducing inflammation and modulating immune responses.
These mechanisms are vital for transplant rejection patients as they help in maintaining the transplanted organ's function and improving long-term health outcomes by preventing the immune system from attacking the new organ.
Tacrolimus. A review of its pharmacology, and therapeutic potential in hepatic and renal transplantation.Late presentation of posterior reversible encephalopathy syndrome following liver transplantation in the setting of tacrolimus and cannabis use.
Tacrolimus. A review of its pharmacology, and therapeutic potential in hepatic and renal transplantation.Late presentation of posterior reversible encephalopathy syndrome following liver transplantation in the setting of tacrolimus and cannabis use.
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
1,042 Previous Clinical Trials
1,316,575 Total Patients Enrolled
Michael Eadon, MDPrincipal InvestigatorIndiana University School of Medicine
Zeruesenay Desta, PhDPrincipal InvestigatorIndiana University School of Medicine
4 Previous Clinical Trials
229 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or have had bad reactions to tacrolimus or cannabidiol.My liver tests show bilirubin or enzymes more than twice the normal limit.I do not have ongoing stomach issues that affect how I absorb pills.I am currently taking medication for sleep or anxiety.Your initial EKG readings show abnormal results that could put you at high risk.I do not use alcohol, drugs, tobacco, or marijuana regularly or can stop using them two weeks before and during the study.My kidney function is very low or I am on dialysis.I am between 18 and 65 years old.You have tested positive for marijuana in a urine drug screen.You work at night.I am unable to understand and give consent for treatment.I have the CYP3A4 *22/*22 genotype.I have a history of seizures or currently experience them.Your hemoglobin level is less than 10.0 grams per deciliter.I am willing to dedicate the necessary time for this study.I have been deemed healthy enough to join based on my medical history, blood and urine tests, and EKG results.My BMI is either below 18.5 or above 35.My kidney function is good and I have low protein in my urine.My kidney function is reduced but not severely, and I have a moderate amount of protein in my urine.I am not on medications that affect how study drugs work.I am not willing to stop taking certain supplements or medicines that could affect the study drugs.I agree not to take any medications or supplements that could affect the study drugs starting 2 weeks before the study.I can avoid smoking or using tobacco/marijuana for the study duration.You have recently participated in a study with a lot of blood tests, or you have donated blood in the last two months.I am currently taking medication that weakens my immune system.I have received an organ or stem cell transplant.I was hospitalized unexpectedly at least once in the past 6 months or twice in the past 2 years.I cannot commit the time needed for this study.
Research Study Groups:
This trial has the following groups:- Group 1: CYP3A5 expressers without chronic kidney disease
- Group 2: CYP3A5 non-expressers without chronic kidney disease
- Group 3: CYP3A5 expressers with chronic kidney disease
- Group 4: CYP3A5 non-expressers with chronic kidney disease
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.