DIalysis Symptom COntrol-Pruritus Outcome Trial

NCT05180968 | Completed Phase 3

• 1 other identifier: B2021:096
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to test whether or not a medication called nabilone, which is a synthetic (non-natural) medication derived from cannabis, compared to placebo improves symptoms of itch in hemodialysis as measured by visual analog scales.

Conditions

End Stage Renal Disease; Pruritus

Keywords

Uremic; Pruritis; Itch; End Stage Renal Disease; Dialysis; Nabilone

Outcome Measures

Primary Outcomes (1)

• Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID

  Measured using Visual Analogue Scale (VAS)

  Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10

Secondary Outcomes (7)

• Number of participants with safety outcomes including adverse events related to study drug

  Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11

• Change in uremic pruritis severity

  Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10

• Change in uremic pruritis severity

  Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10

• Change in health-related quality of life

  Measured at study baseline and weeks 3 and 4 of each crossover

• Change in health-related quality of life

  Measured at study baseline and weeks 3 and 4 of each crossover

Study Arms (2)

Nabilone 0.5mg

EXPERIMENTAL

Subjects will receive nabilone 0.5 mg orally at night for 1 week increased to nabilone 0.5mg orally twice a day for 3 weeks (over-encapsulated). Drug will be dispensed from a central site to other sites and pharmacy personnel will dispense the study medications directly to research personnel or participants. Drug dispensation will coincide with study visits at randomization and crossover and will allow research personnel to reinforced adherence. The study oral medications may be taken at any time of day with food or water, but we will request that participants take it at the same time each day, preferably at night when uremic pruritus symptoms are usually at the worst. If participants have any side effects or intolerability to study drugs, they may decrease the frequency of nabilone or placebo to 1 capsule by mouth once daily, preferably taken at night.

Drug: Nabilone 0.5 MG Oral Capsule

Oral placebo

PLACEBO COMPARATOR

Subjects will receive placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks (over-encapsulated). Drug will be dispensed from a central site to other sites and pharmacy personnel will dispense the study medications directly to research personnel or participants. Drug dispensation will coincide with study visits at randomization and crossover and will allow research personnel to reinforced adherence. The study oral medications may be taken at any time of day with food or water, but we will request that participants take it at the same time each day, preferably at night when uremic pruritus symptoms are usually at the worst. If participants have any side effects or intolerability to study drugs, they may decrease the frequency of nabilone or placebo to 1 capsule by mouth once daily, preferably taken at night.

Drug: Placebo Nabilone

Interventions

Nabilone 0.5 MG Oral Capsule DRUG

This intervention will consist of subjects receiving nabilone 0.5 mg orally at night for 1 week increased to nabilone 0.5mg orally twice a day for 3 weeks. Duration of the intervention will be 4 weeks.

Also known as: TEVA-Nabilone

Nabilone 0.5mg

Placebo Nabilone DRUG

This intervention will consist of subjects receiving placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks. Duration of the intervention will be 4 weeks.

Also known as: TEVA-Nabilone Placebo

Oral placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>25 years
• In-center or home hemodialysis at least two times weekly or peritoneal dialysis at least once daily for \>90 days
• Generalized uremic pruritus with a mean worst VAS\>40mm over the previous week (with at least 5/7 patient diary days completed)
• ALT less or equal to 3x upper limit of normal and bilirubin less than or equal to 2x upper limit of normal in the last 90 days
• Able to provide informed consent and complete patient reported outcome measurements without a language barrier or cognitive impairment

You may not qualify if:

• Etiology of pruritus (in the opinion of the treating physician) thought to be secondary to primary dermatologic condition, liver disease, hematologic malignancy or allergy
• Use of recreational or medical cannabis in the last 4 weeks (THC, CBD, nabilone, Sativex, Epidiolex)
• Women of childbearing potential as assessed by their clinician regardless of abstinence from sex or the use of contraception
• Planned kidney transplantation, travel or relocation in the next 3 months
• Unstable psychiatric illness (the presence of a lifetime diagnosis of a psychotic disorder, bipolar disorder, substance use disorder or current suicidal ideation)
• Symptomatic hypotension in the last 2 weeks defined as a systolic blood pressure (SBP) less than 90mmHg during or in between dialysis requiring an intervention (i.e. administration of crystalloid or colloid, termination of dialysis, change in pharmacologic therapy such as withdrawal of anti-hypertensive therapy or initiation/titration of midodrine, increase in dry weight)
• History of hypersensitivity to any cannabinoid
• Presence of any clinically significant or unstable medical conditions, including cardiovascular, liver, pulmonary disease

Sponsors & Collaborators

• University of Manitoba: lead
• Population Health Research Institute: collaborator

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G2P4, Canada

Location

Seven Oaks General Hospital

Winnipeg, Manitoba, R2V 3M3, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Pruritus

Interventions

nabilone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms

Study Officials

• David Collister, MD, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 6, 2022
• Study Start: August 2, 2022
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)