PRIMARY STUDY

Pharmacokinetics and Side Effects of Δ9-Tetrahydrocannabinol and Cannabidiol in Patients with Different Stages of CKD

Key Findings:  In patients with chronic kidney disease (CKD), either stage 4 or stage 5, the exposure to Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and their metabolites was higher than in the matched control group. Additional caution and monitoring may be needed in patients with CKD, as the side effects may be more pronounced, and adequate dosing may be lower.

Type of Study:  Clinical Trial

Study Sample Size:  49

Study Result:  Negative

Research Location(s):  Denmark

Year of Pub:  2025


Cannabinoids Studied:  Cannabidiol (CBD), Tetrahydrocannabinol (THC), Pharma THC:CBD

Phytocannabinoid Source:  Not Applicable

Chemotype:  Chemotype II

DOSING DETAILS   

Study Dosing Objective:  Safety Profile,

Established Protocol:  Adverse effects

Route of Administration:  , Oral (Ingestion), Sublingual/Oromucosal

Cannabinoid Ratio:  (Pharma THC:CBD : THC : CBD)   1 : 1 : 1    

Dosage Form:  Sativex (THC 5.4 mg and CBD 5mg)

Clinical Relevance:  Exposure to THC, CBD, and metabolites was higher in patients with CKD stages 4 and 5 compared with controls, and side effects appeared more pronounced.

Adverse Events:  Scores for dizziness were significantly higher for each CKD group compared with controls.

Additional Notes:  Pharmacokinetic Study Data




Citation:  Sønderskov MB, Khatir DS, Kjærgaard KD, Hasselstrøm JB, Sørensen LK, Sædder EA, Andersen CU. Pharmacokinetics and Side Effects of Δ9-Tetrahydrocannabinol and Cannabidiol in Patients with Different Stages of CKD. Kidney Int Rep. 2024 Dec 30;10(3):707-719. doi: 10.1016/j.ekir.2024.12.030. PMID: 40225360; PMCID: PMC11993231.