THC + CBD for Chronic Kidney Disease
(POT-GFR-PK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) affects individuals with chronic kidney disease, including those on regular dialysis. The goal is to understand how the body processes these compounds when taken orally. It suits adults who have been undergoing dialysis treatments at least twice a week for three hours each time. Participants should not have used cannabis recently or have a history of significant psychiatric disorders. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that interact with THC or CBD, such as anti-epileptic drugs, calcineurin inhibitors, or anti-fungal medications. It's best to discuss your current medications with the trial team to see if any changes are needed.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that THC (tetrahydrocannabinol) and CBD (cannabidiol) affect individuals with kidney problems differently. Studies found that people with severe chronic kidney disease (CKD) had higher levels of THC and CBD in their bodies compared to healthy individuals, potentially leading to stronger side effects. Some experts believe cannabis could accelerate kidney function decline in those with kidney issues. While cannabis does not appear to harm kidney function in healthy individuals, those with CKD require close monitoring. Overall, insufficient information exists to recommend these drugs for individuals with advanced CKD, so safety should be considered carefully.12345
Why do researchers think this study treatment might be promising for chronic kidney disease?
Researchers are excited about the THC and CBD treatment for chronic kidney disease because it offers a unique approach compared to standard treatments like blood pressure medications and dietary changes. Unlike these traditional options, this treatment uses a combination of cannabinoids — THC and CBD — which are active compounds derived from cannabis plants. These compounds may have anti-inflammatory and pain-relieving properties, providing a potential new mechanism for managing symptoms associated with chronic kidney disease. The oral administration of THC and CBD could offer patients a more natural and potentially less invasive alternative to existing therapies.
What evidence suggests that this treatment might be an effective treatment for chronic kidney disease?
Research has shown that combining THC (tetrahydrocannabinol) and CBD (cannabidiol) might alleviate symptoms in people with advanced chronic kidney disease (CKD). Some studies suggest it could help manage pain in these patients. However, individuals with CKD stages 4 and 5 may experience higher levels of THC and CBD in their bodies, potentially leading to more noticeable side effects. This trial will investigate whether this combination effectively addresses CKD symptoms. While signs of possible benefits exist, further research is needed for confirmation.14567
Who Is on the Research Team?
Michael Walsh, MD, PhD
Principal Investigator
McMaster University
Are You a Good Fit for This Trial?
This trial is for adults over 25 with chronic kidney disease, including those on hemodialysis. Participants must have a body mass index between 20 and 35, no drug dependence (except caffeine or nicotine), no recent cannabis use, and not be taking certain medications that interact with THC/CBD.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of oral THC and CBD, followed by blood, urine, and dialysate sample collection
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and vital signs
What Are the Treatments Tested in This Trial?
Interventions
- Tetrahydrocannabinol-Cannabidiol Combination
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
Center for Medicinal Cannabis Research
Collaborator