A pilot study of safety, tolerability and pharmacokinetics of cannabidiol therapy in symptomatic kidney failure

Phase 2

Completed

• Conditions: Chronic symptoms management in chronic kidney disease patients; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12622000383763
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-04
• Study Completion: 2024-04-04
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1.Adults greater than or equal to 18 years with kidney failure as defined by:
a.eGFR less than or equal to 15ml/min/1.73m2 (measured by Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] equation) on at least two blood tests within the past three (3) months
OR
b.receiving maintenance dialysis (haemodialysis or peritoneal dialysis),
2.A score of greater than or equal to 4 on at least one of the following domains of ESASr-Renal: pain, nausea, lack of appetite, itching, problem sleeping, restless legs, tiredness, and
3.Participant and treating clinician are willing to perform the study procedures.

Exclusion Criteria

1.Active on the kidney transplant waitlist
2.Taking a disqualifying concomitant medication that cannot be ceased during the study period.
3.Use of recreational or prescribed cannabis products in the past 4 weeks and unwilling to refrain from using such products for the duration of the present study.
4.Unstable mood disorder. Defined as commencing therapy for depression or anxiety (pharmacotherapy or non-pharmacotherapy) within the past 3 months, or in the opinion of the investigator.
5.Pregnant or breast-feeding
6.Significant hepatic disease, defined as either of the following
a.Known or suspected cirrhosis (of any degree)
b.Elevated liver enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or gamma-glutamyl transferase [GGT]) more than 2x the upper limit of normal on blood tests taken within 3 months of the date of screening.
7.Unwilling or unable to follow study procedures
8.Unwilling or unable to refrain from driving within 24 hours of receiving THC wafer.
9.In the opinion of the treating investigator: death likely within three months
10.Taking clopidogrel AND meeting at least ONE of the following conditions in the past (6) months:
a.Placement of a coronary artery stent
b.Acute myocardial infarction
c.Cerebrovascular accident

Study & Design

• Study Type: Interventional
• Study Design: Not specified