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Cannabidiol + Tacrolimus for Transplant Rejection
Study Summary
This trialaims to find the best dose of drugs to help transplant patients have a better recovery and long-term health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- 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.
- 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
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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"
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