DIalysis Symptom COntrol-Pruritus Outcome Trial

End Stage Renal Disease Clinical Trial

— DISCO-POT  

Official title:

Dialysis Symptom Control-Pruritus Outcome Trial: A Randomized Blinded Placebo Controlled Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05180968
• Other study ID #: B2021:096
• Status: Completed
• Phase: Phase 3
• Start date: August 2, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: November 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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:

1. nabilone 0.5 mg orally at night for 1 week increased to nabilone 0.5mg orally twice a day for 3 weeks (over-encapsulated)

2. placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks (over-encapsulated)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

1. Age>25 years

2. In-center or home hemodialysis at least two times weekly or peritoneal dialysis at least once daily for >90 days

3. Generalized uremic pruritus with a mean worst VAS>40mm over the previous week (with at least 5/7 patient diary days completed)

4. 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

5. Able to provide informed consent and complete patient reported outcome measurements without a language barrier or cognitive impairment

Exclusion Criteria:

1. Etiology of pruritus (in the opinion of the treating physician) thought to be secondary to primary dermatologic condition, liver disease, hematologic malignancy or allergy

2. Use of recreational or medical cannabis in the last 4 weeks (THC, CBD, nabilone, Sativex, Epidiolex)

3. Women of childbearing potential as assessed by their clinician regardless of abstinence from sex or the use of contraception

4. Planned kidney transplantation, travel or relocation in the next 3 months

5. Unstable psychiatric illness (the presence of a lifetime diagnosis of a psychotic disorder, bipolar disorder, substance use disorder or current suicidal ideation)

6. 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)

7. History of hypersensitivity to any cannabinoid

8. Presence of any clinically significant or unstable medical conditions, including cardiovascular, liver, pulmonary disease

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Pruritus

Intervention

Drug:
• Nabilone 0.5 MG Oral Capsule
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 Nabilone
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.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Seven Oaks General Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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