Back to resultsDIalysis Symptom COntrol-Pruritus Outcome Trial (DISCO-POT)
Primary Purpose
End Stage Renal Disease, Pruritus
Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Nabilone 0.5 MG Oral Capsule
Placebo Nabilone
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Uremic, Pruritis, Itch, End Stage Renal Disease, Dialysis, Nabilone
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Seven Oaks General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nabilone 0.5mg
Oral placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID
Measured using Visual Analogue Scale (VAS)
Secondary Outcome Measures
Number of participants with safety outcomes including adverse events related to study drug
serious adverse events, adverse events leading to drug discontinuation, hospitalization or emergency room visit for altered level of consciousness, fall, fracture, death, symptomatic hypotension requiring an intervention
Change in uremic pruritis severity
Measured as change from baseline in mean Visual Analogue Scale (VAS)
Change in uremic pruritis severity
Measured as change from baseline in mean Verbal Rating Scale (VRS)
Change in health-related quality of life
Measured using the Dermatology Quality of Life Index (DLQI)
Change in health-related quality of life
Measured using the EQ-5D 5 Level (EQ-5D-5L)
Change in health-related quality of life
Measured using the Patient Global Impression (PGI)
Effect of nabilone on sleep quality
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Full Information
NCT ID
NCT05180968
First Posted
November 24, 2021
Last Updated
March 9, 2023
Sponsor
University of Manitoba
Collaborators
Population Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05180968
Brief Title
DIalysis Symptom COntrol-Pruritus Outcome Trial
Acronym
DISCO-POT
Official Title
Dialysis Symptom Control-Pruritus Outcome Trial: A Randomized Blinded Placebo Controlled Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Population Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Several different types of medications are effective in treating uremic pruritus, but even with effective treatments, residual symptoms are common and some medications are not well tolerated. Standard of care treatments include emollients which are lotions that keep the skin hydrated and a variety of pills that target the itch pathways implicated in the disease.
The objective of the study is to determine the proportion of patients with kidney failure for whom oral nabilone provides important benefit in reducing uremic pruritis without important adverse effects. The hypothesis is that there is a substantial proportion of patients in whom oral nabilone are safe and effective beyond placebo effects.
Nabilone is currently used to treat conditions other that uremic pruritus including chronic nerve pain as well as nausea and vomiting due to chemotherapy. It has never been studied in the setting of kidney disease.
DISCO-POT is a blinded, placebo-controlled crossover trial in which participants will be followed for 11 weeks including two 4 week treatment crossover periods with a 2 week washout period in between them and an end of study visit after 1 week off study drugs.
Patients that are eligible will be randomly assigned to a crossover treatment sequence of two treatments:
nabilone 0.5 mg orally at night for 1 week increased to nabilone 0.5mg orally twice a day for 3 weeks (over-encapsulated)
placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks (over-encapsulated)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Pruritus
Keywords
Uremic, Pruritis, Itch, End Stage Renal Disease, Dialysis, Nabilone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nabilone 0.5mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Oral placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nabilone 0.5 MG Oral Capsule
Other Intervention Name(s)
TEVA-Nabilone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Nabilone
Other Intervention Name(s)
TEVA-Nabilone Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID
Description
Measured using Visual Analogue Scale (VAS)
Time Frame
Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10
Secondary Outcome Measure Information:
Title
Number of participants with safety outcomes including adverse events related to study drug
Description
serious adverse events, adverse events leading to drug discontinuation, hospitalization or emergency room visit for altered level of consciousness, fall, fracture, death, symptomatic hypotension requiring an intervention
Time Frame
Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11
Title
Change in uremic pruritis severity
Description
Measured as change from baseline in mean Visual Analogue Scale (VAS)
Time Frame
Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10
Title
Change in uremic pruritis severity
Description
Measured as change from baseline in mean Verbal Rating Scale (VRS)
Time Frame
Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10
Title
Change in health-related quality of life
Description
Measured using the Dermatology Quality of Life Index (DLQI)
Time Frame
Measured at study baseline and weeks 3 and 4 of each crossover
Title
Change in health-related quality of life
Description
Measured using the EQ-5D 5 Level (EQ-5D-5L)
Time Frame
Measured at study baseline and weeks 3 and 4 of each crossover
Title
Change in health-related quality of life
Description
Measured using the Patient Global Impression (PGI)
Time Frame
Measured at study baseline and weeks 3 and 4 of each crossover
Title
Effect of nabilone on sleep quality
Description
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Measured at study baseline and weeks 3 and 4 of each crossover
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Collister, MD, PhD
Phone
780-492-8618
Email
dcollist@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rocio Ayala Romero, MSc
Phone
780-492-3284
Email
ayalarom@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Collister, MD, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seven Oaks General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 3M3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Collister, MD, PhD
Phone
780-492-8618
Email
dcollist@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Rocio Ayala Romero, MSc
Phone
780-492-3284
Email
ayalarom@ualberta.ca
First Name & Middle Initial & Last Name & Degree
David Collister, MD, PhD
First Name & Middle Initial & Last Name & Degree
Navdeep Tangri, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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DIalysis Symptom COntrol-Pruritus Outcome Trial
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