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Kidney Week

Abstract: TH-PO1192

DIalysis Symptom COntrol-Pruritus Outcome Trial (DISCO-POT): A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Crossover Trial

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Collister, David Thomas, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada
  • Cherepak, Kathy, Chronic Disease Innovation Center, Winnipeg, Manitoba, Canada
  • Tangri, Navdeep, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada
  • Walsh, Michael, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada

Group or Team Name

  • DISCO-POT Investigators.
Background

Uremic pruritus affects 50% of patients with kidney failure and negatively impacts quality of life. Itch often persists despite effective pharmacologic treatments. Cannabinoids may reduce pruritus. We evaluated nabilone, a synthetic cannabinoid, to treat uremic pruritus.

Methods

Eligible participants were adults age>25 years receiving in-center or home hemodialysis at least 2x weekly or peritoneal dialysis daily for at least 90 days and at least moderate itch defined by a mean worst visual analogue scale (VAS) >40mm during a 1-week screening period. Participants were randomly allocated to oral nabilone 0.5mg daily x 1 week then nabilone 0.5mg twice a day x 3 weeks or an identical placebo regimen. Then, after a 2-week washout, participants received an identical regimen of nabilone or placebo, whichever they did not receive in the first treatment period. The primary outcome was the difference in worst VAS over the last 24 hours over each 4 week crossover period.

Results

Of 14 participants randomized, the mean (SD) age was 60.5 (12.7) years, 4 (28.6%) were female sex, 8 (57.1%) had diabetes, and all were on hemodialysis for a mean (SD) of 3.29 (0.73) sessions per week for a mean (SD) 4.04 (0.50) hours/treatment. The mean (SD) worst VAS was 69mm (25). Baseline co-interventions included topical emollients in 12 (85.7%) and alpha 2 delta ligands in 7 (50%). Self-reported and pill count adherence was >90%. Nabilone did not reduce the worst VAS to a greater extent than placebo (Figure 1). The worst VAS was 4.79 (95% CI -3.95 to 13.5, p=0.28) higher with nabilone compared to placebo, indicating worse itch. Nabilone also had no effect on other measures of itch, sleep, quality of life or adverse events.

Conclusion

This small trial detected no effect of nabilone on uremic pruritus compared to placebo. (ClinicalTrials.gov NCT05180968)

Funding

  • Government Support - Non-U.S.