THC + CBD for Chronic Kidney Disease

(POT-GFR-PK Trial)

MW
DC
Overseen ByDavid Collister, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

MW

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

You are older than 25 years old.
Your kidney function, measured by eGFR, should be within a certain range. If you are on hemodialysis, it should be through a tunnelled catheter for at least 3 hours per session, at least 2 times per week for more than 90 days.
Agree to take the medication as directed in the study
See 1 more

Exclusion Criteria

You have had a serious bad reaction to using cannabis.
You have a history of serious mental health issues like psychosis or mania.
You have used any form of marijuana or synthetic cannabinoids in the last 30 days.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of oral THC and CBD, followed by blood, urine, and dialysate sample collection

48 hours
Multiple visits for sample collection within 48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and vital signs

48 hours

What Are the Treatments Tested in This Trial?

Interventions

  • Tetrahydrocannabinol-Cannabidiol Combination
Trial Overview The study tests how single doses of oral tetrahydrocannabinol (THC) and cannabidiol (CBD) are processed by the body in healthy individuals compared to those with chronic kidney disease, including patients undergoing regular hemodialysis treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: THC/CBDExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Center for Medicinal Cannabis Research

Collaborator

Trials
19
Recruited
630+

Citations

Clinical Research Pharmacokinetics and Side Effects of Δ 9Total exposure to THC, CBD, and metabolites was higher in patients with CKD stages 4 and 5 compared with controls, and side effects may be more pronounced.
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40225360/
Pharmacokinetics and Side Effects of Δ 9Conclusion: Total exposure to THC, CBD, and metabolites was higher in patients with CKD stages 4 and 5 compared with controls, and side effects ...
Will Cannabinoids Prove Useful and Safe for Those With ...The biggest question is whether THC, CBD, or their combination, is efficacious for any of the symptoms commonly associated with CKD and kidney ...
Renal Outcomes and Other Adverse Effects of ...This narrative review explores the benefits and risks of cannabinoids in kidney health, particularly in individuals with pre-existing renal conditions.
The nephrologist's guide to cannabis and cannabinoidsCannabis may have medicinal benefits for treating symptoms of advanced chronic kidney disease (CKD) and end-stage renal disease including as a pain adjuvant.
The nephrologist's guide to cannabis and cannabinoidsCannabis does not seem to affect kidney function in healthy individuals. However, renal function should be closely monitored in those with CKD, the lowest ...
Cannabis and Kidney Disease–What You Need to KnowDr. Rein's retrospective cohort study found that people who used cannabis had a faster decline in kidney function than those who didn't.
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