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Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease
Sponsor: Chittagong Medical College
Summary
A randomized, placebo-controlled, double-blind trial will be conducted in the Department of Nephrology at Chittagong Medical College Hospital, Chattogram, Bangladesh, over a period of one and a half years. A total of 102 patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis will be enrolled in the study. Patients with moderate-to-severe pruritus, defined as a Worst Itching Intensity Numerical Rating Scale (WI-NRS) score ≥ 4, will be included. Eligible participants will be randomly assigned in a 1:1 ratio to receive either difelikefalin (0.5 mcg/kg) or placebo administered intravenously after each hemodialysis session for 6 weeks. The primary outcome measure will be the change in WI-NRS score from baseline to week 6. Secondary outcomes will include changes in quality of life assessed using the Skindex-10 scale. Adverse events and safety parameters will also be monitored throughout the study period. The primary analysis will be conducted using the intention-to-treat principle. A per-protocol analysis may also be performed as a secondary analysis. Statistical analysis will be carried out using SPSS version 27.
Official title: Effect of Difelikefalin on CKD-Associated Pruritus in Patients on Maintenance Hemodialysis: A Randomized, Placebo-Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2026-04-26
Completion Date
2027-01-30
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Difelikefalin Injection
ntravenous difelikefalin (κ-opioid receptor agonist) administered at a dose of 0.5 mcg/kg at the end of each hemodialysis session, three times weekly,for a total duration of 6 wks in patients undergoing maintenance hemodialysis with moderate to severe CKD -associated pruritus
Normal Saline (0.9% NaCl)
Intravenous normal saline will be administered at the end of each hemodialysis session, three times per week, for a total duration of 6 weeks, in a volume equivalent to the difelikefalin dose.