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| Name | Class |
|---|---|
| Population Health Research Institute | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Collister, MD, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G2P4 | Canada | ||
| Seven Oaks General Hospital |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C011941 | nabilone |
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| 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. |
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| Change in uremic pruritis severity | Measured as change from baseline in mean Visual Analogue Scale (VAS) | 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 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 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 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 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 at study baseline and weeks 3 and 4 of each crossover |
| Winnipeg |
| Manitoba |
| R2V 3M3 |
| Canada |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |