Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease

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.

Timeline

Start

2026-04-26

Primary completion

2027-01-30

Completion

2027-01-30

Drugs

Indications