Cannabidiol + Tacrolimus for Transplant Rejection
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription medications, over-the-counter medications, and herbal, dietary, and alternative supplements that may interact with the study drugs at least 2 weeks before the study starts and until it is completed.
What data supports the effectiveness of the drug combination of Cannabidiol and Tacrolimus for transplant rejection?
Tacrolimus is an effective drug for preventing organ rejection after transplantation, as it inhibits the growth of certain immune cells that can attack the transplanted organ. While there is no direct evidence for the combination with Cannabidiol, Tacrolimus has been shown to be a useful alternative to other immunosuppressants in transplant patients.12345
How is the drug combination of Cannabidiol and Tacrolimus unique for transplant rejection?
This drug combination is unique because it combines Cannabidiol (CBD), known for its anti-inflammatory properties, with Tacrolimus, an immunosuppressant that prevents organ rejection by inhibiting T-cell growth. The combination may offer a novel approach by potentially enhancing the immunosuppressive effects while reducing inflammation, which is different from standard treatments that typically focus solely on immunosuppression.12367
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cannabidiol and tacrolimus to study drug-gene and drug-drug interactions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Epidiolex (Cannabinoid)
- Tacrolimus (Immunosuppressant)
Epidiolex is already approved in United States, European Union for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome