End Stage Renal DiseasePhase 3DISCO-POTNCT05180968
DIalysis Symptom COntrol-Pruritus Outcome Trial
A Phase 3 study testing Nabilone 0.5 MG Oral Capsule in people with End Stage Renal Disease and Pruritus, run by University of Manitoba at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- End Stage Renal Disease, Pruritus
- What is being tested?
- Nabilone 0.5 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesCanada
- Study dates
- 2 Aug 2022to 11 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta, T6G2P4
Seven Oaks General Hospital
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Dialysis Symptom Control-Pruritus Outcome Trial: A Randomized Blinded Placebo Controlled Crossover Trial
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.
Read the 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)
- Conditions
- End Stage Renal Disease, Pruritus
- Being tested
- Nabilone 0.5 MG Oral Capsule, Placebo Nabilone
- Keywords
- Uremic, Pruritis, Itch, End Stage Renal Disease, Dialysis, Nabilone
- Medical subject headings
- Kidney Failure, Chronic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nabilone 0.5 MG Oral CapsuleDrug
Also called TEVA-Nabilone
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.
Placebo NabiloneDrug
Also called TEVA-Nabilone Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Nabilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID
Measured using Visual Analogue Scale (VAS)
Measured: 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
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
Measured: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11
Change in uremic pruritis severity
Measured as change from baseline in mean Visual Analogue Scale (VAS)
Measured: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10
Change in uremic pruritis severity
Measured as change from baseline in mean Verbal Rating Scale (VRS)
Measured: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10
Change in health-related quality of life
Measured using the Dermatology Quality of Life Index (DLQI)
Measured: Measured at study baseline and weeks 3 and 4 of each crossover
Change in health-related quality of life
Measured using the EQ-5D 5 Level (EQ-5D-5L)
Measured: Measured at study baseline and weeks 3 and 4 of each crossover
Change in health-related quality of life
Measured using the Patient Global Impression (PGI)
Measured: Measured at study baseline and weeks 3 and 4 of each crossover
Effect of nabilone on sleep quality
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Measured: Measured at study baseline and weeks 3 and 4 of each crossover
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start2 Aug 2022
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Principal investigator, David Collister, University of Manitoba
- Investigators
- David Collister, MD, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180968
- Sponsor's protocol ID
- B2021:096
- Acronym
- DISCO-POT
- Status last verified
- Nov 2023
- First submitted
- 24 Nov 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis Symptom Control-Pruritus Outcome Trial: A Randomized Blinded Placebo Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT05180968
- Acronym / sponsor ID
- DISCO-POT / B2021:096
- Conditions
- End Stage Renal Disease, Pruritus
- Keywords
- Uremic, Pruritis, Itch, End Stage Renal Disease, Dialysis, Nabilone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nabilone 0.5mg | Experimental | Drug: Nabilone 0.5 MG Oral CapsuleSubjects 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. |
| Oral placebo | Placebo comparator | Drug: Placebo NabiloneSubjects 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nabilone 0.5 MG Oral CapsuleAlso: TEVA-NabiloneThis 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. | Drug | Nabilone 0.5mg |
| Placebo NabiloneAlso: TEVA-Nabilone PlaceboThis 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. | Drug | Oral placebo |
Primary outcome
Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID
Time frame: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10
Measured using Visual Analogue Scale (VAS)
7 secondary outcomes
Number of participants with safety outcomes including adverse events related to study drug
Time frame: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11
Change in uremic pruritis severity
Time frame: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10
Change in uremic pruritis severity
Time frame: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10
Change in health-related quality of life
Time frame: Measured at study baseline and weeks 3 and 4 of each crossover
Change in health-related quality of life
Time frame: Measured at study baseline and weeks 3 and 4 of each crossover
Change in health-related quality of life
Time frame: Measured at study baseline and weeks 3 and 4 of each crossover
Effect of nabilone on sleep quality
Time frame: Measured at study baseline and weeks 3 and 4 of each crossover
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Collister, MD, PhD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nabilone 0.5 MG Oral Capsule in people with End Stage Renal Disease and Pruritus, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID (time frame: Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.