Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease
Starting soon · Not applicable · Has a placebo group
Conditions studied: Itching Symptoms, CKD 5D, Hemodialysis
In brief
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.
Key facts
- Study ID
- NCT07526324
- Run by
- Chittagong Medical College
- People needed
- 106
- Starts
- 2026-04-26
- Expected to finish
- 2027-01-30
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients aged ≥18 years
- Diagnosed with chronic kidney disease (CKD) on maintenance hemodialysis Undergoing hemodialysis for at least 3 months
- Presence of moderate-to-severe pruritus defined as Worst Itching Intensity Numerical Rating Scale (WI-NRS) score ≥4
- Able and willing to provide written informed consent
You may not qualify if…
- Known case of Primary skin disesease associated with Itching.
- Known case of liver disease.
- Known case of iron defeciency anaemia ,hematological malignancy.
- Known case of hypothyroidism \& hyperthyroidism.
- Known case of allergic reaction to Opiates .
- Pregnancy.
- Drug abuse, or substance dependence
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