Systematic Evaluation of Interventions for Symptom Management In Chronic kidney disease: CannaBiDiol (SEISMIC: CBD)

 

Background:

Kidney failure affects over 15,000 Australians. Many suffer a variety of symptoms such as pain, itch, nausea, anorexia, restless legs, difficulty sleeping and fatigue. There are few treatments available, and many symptoms do not get better or go untreated. Medicinal cannabis is known to help some health problems, including muscle spasms, pain, and nausea. It may also help with symptoms in people with poor kidney function. Despite this, medicinal cannabis has never been tested in people with poor kidney function. SEISMIC-CBD is a world-first study testing cannabidiol (CBD) – one of two key active components of cannabis - in people with kidney failure. It will help us find out how people with poor kidney function feel when they use CBD, what dosage to use, and if there are any safety concerns.

The results of this study will provide doctors and patients with important information about how cannabis wafers, and medicines derived from cannabis in general, might be used in people with symptoms associated with kidney failure.

 

Research Methodology:

SEISMIC-CBD is a prospective, single-arm, open-label, dose titration and safety study. It is a pilot study ahead of the development and delivery of the wider SEISMIC platform.

The study consists of a 6-week treatment period:

  1. Treatment with CBD (given as oral, fast dissolving wafers).

Participants will take CBD wafers for the first 6 weeks of the study. The dosing will slowly increase until the participant finds the amount that best helps their symptoms. 

Participants will be recruited through the Renal Supportive Care Clinic at St George Hospital.

 

 Aim:

The aim of the research is to determine the safety, tolerability, and pharmacokinetics of cannabis wafers in people with kidney failure.

Supported by:

NHMRC Clinical Trials Centre

Eligibility:

Inclusion criteria

  1. Adults (≥18 years) with kidney failure as defined by:

a. eGFR ≤15ml/min/1.73m2    OR     b. receiving maintenance dialysis

2. A score of ≥4 on at least one of the following domains of ESASr-Renal: pain, nausea, lack of appetite, itching, problems sleeping, restless legs and tiredness.

3. Participants and treating clinicians are willing to perform the study procedures.

Exclusion criteria include

  1. Active on the kidney transplant waitlist
  2. Taking a medication with a potential interaction with CBD 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 study
  4. Pregnant or breast-feeding
  5. Significant hepatic disease
  6. Unwilling or unable to follow study procedures
  7. In the opinion of the treating investigator: death likely within three months

Registration ID:

ACTRN12622000383763

Participation:

Australia

Australian Lead Group:

NHMRC Clinical Trials Centre

Status:

Recruiting

Activation Date:

22 Feb 2023

Chair:

Dr Brendan Smyth

Contact:

seismic.study@sydney.edu.au

Publications:

Worth H, O'Hara D, Agarwal N, Collister D, Brennan F, Smyth B. Cannabinoids for Symptom Management in Patients with Kidney Failure. Clin J Am Soc Nephrol. 2022 Jan 5. doi: 10.2215/CJN.11560821