Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05490511
Other study ID # 12763
Secondary ID 5R01AT011463-02
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 31, 2022
Est. completion date October 2028

Study information

Verified date April 2024
Source Indiana University
Contact Michael Eadon, MD
Phone (317) 274-2502
Email meadon@iupui.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The information learned in these studies will help to inform doctors as to how to appropriately adjust doses of cannabidiol and tacrolimus in order to improve health outcomes and long-term treatment success for transplant recipients.


Description:

The commercial availability of cannabidiol, or CBD oil, has increased in the United Stated and this supplement has the potential to cause a variety of drug-drug interactions, including in solid organ transplant recipients who receive tacrolimus to prevent rejection. Through a series of pharmacokinetic and pharmacodynamics assays, this proposal will identify gene-drug and drug-drug interactions (DDI), including those that place transplant recipients at risk for increased toxicity related to their immunosuppression. The information learned in these studies will help to inform practitioners as to whether cannabidiol needs to be avoided in transplant recipients and how to appropriately adjust doses of CBD and immunosuppression in order to improve health outcomes and long-term treatment success in this high-risk population.


Read more »

Study Design


Intervention

Drug:
Tacrolimus single dose
5 mg once
Epidiolex single dose
Epidiolex 5 mg/kg
Epidiolex steady-state and tacrolimus single dose
Epidiolex at up to 5 mg/kg twice daily (for 14 days) and tacrolimus 5 mg once on day 12 of period

Locations

Country Name City State
United States IU Health University Hospital Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University The National Center for Complementary and Integrative Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

Birdwell KA, Decker B, Barbarino JM, Peterson JF, Stein CM, Sadee W, Wang D, Vinks AA, He Y, Swen JJ, Leeder JS, van Schaik R, Thummel KE, Klein TE, Caudle KE, MacPhee IA. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP3A5 Genotype and Tacrolimus Dosing. Clin Pharmacol Ther. 2015 Jul;98(1):19-24. doi: 10.1002/cpt.113. Epub 2015 Jun 3. — View Citation

Brown JD, Winterstein AG. Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. J Clin Med. 2019 Jul 8;8(7):989. doi: 10.3390/jcm8070989. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The AUC0-Infinity ratio of tacrolimus with cannabidiol divided by tacrolimus alone The primary outcome is the AUC0-Infinity ratio of tacrolimus with cannabidiol divided by tacrolimus alone between CYP3A5 expressers and non-expressers in subjects with and without chronic kidney disease (CKD). Subjects with and without CKD will be analyzed separately. 27 days
Secondary Immune cell distribution and signaling as measured by scRNA sequencing Immune cell distribution and signaling as measured by scRNA sequencing. The hypothesis tested is that cannabidiol will induce T regulatory lymphocytes (Tregs) and reduce overall cytokine signaling as compared to tacrolimus alone. Period 1 and Period 3 will be compared. 27 days
See also
  Status Clinical Trial Phase
Completed NCT03907657 - Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau Phase 2
Not yet recruiting NCT06223750 - Virtual Kidney Check and Follow-up N/A
Completed NCT02468401 - Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions N/A
Completed NCT02238067 - Survey on Anemia Therapy in Patients With Chronic Kidney Disease Not on Dialysis N/A
Completed NCT01194154 - A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA) Phase 2
Completed NCT02263833 - An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice N/A
Active, not recruiting NCT04078750 - PLATO - Medication Adherence in Transplant Recipients N/A
Terminated NCT05747053 - Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Completed NCT03189212 - Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation N/A
Enrolling by invitation NCT05374291 - The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD Phase 3
Recruiting NCT05033054 - Effect of SGLT2i on Cardiovascular Biomarkers in Patients With Type 2 Diabetes and CKD Stage 3b-4
Completed NCT05064267 - Hemostatic Profiles in Pediatric CKD
Not yet recruiting NCT06069518 - Continuous Glucose Monitoring in Patients With Diabetes on Peritoneal Dialysis
Not yet recruiting NCT03590067 - Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease
Recruiting NCT04014127 - Coronary Microvascular Dysfunction in Chronic Kidney Disease
Recruiting NCT04626323 - Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease Phase 2
Not yet recruiting NCT05774392 - An Observational Study of Patients With Chronic Kidney Disease
Not yet recruiting NCT06343727 - A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF) N/A
Completed NCT04515797 - QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir Phase 4
Completed NCT03850756 - Early Diagnosis of Kidney Damage Associated With Tobacco Use