Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease

NCT07526324 | Not Yet Recruiting DMC

• 1 other identifier: 59.127.1557.013.19.PG.1238
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Itching Symptoms; CKD 5D, Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Worst Itching Intensity Numerical Rating Scale (WI-NRS) Score at 6 Weeks

  The Worst Itching Intensity Numerical Rating Scale (WI-NRS) is an 11-point scale ranging from 0 (no itching) to 10 (worst imaginable itching). The outcome will be reported as the mean change in WI-NRS score from baseline to week 6

  Baseline to Week 6

Secondary Outcomes (1)

• Change From Baseline in Skindex-10 Score at 6 Weeks

  Baseline to Week 6

Study Arms (2)

Difelikefalin Group

EXPERIMENTAL

Difelikefalin (0.5 mcg/kg) will be administered intravenously at the end of each hemodialysis session, three times per week, for a total duration of 6 weeks in patients with CKD-associated pruritus.

Drug: Difelikefalin Injection

Placebo (Normal Saline) Group

PLACEBO COMPARATOR

Participants will receive intravenous normal saline at the end of each hemodialysis session, three times per week, for 6 weeks, administered in a volume equivalent to the difelikefalin dose

Drug: Normal Saline (0.9% NaCl)

Interventions

Difelikefalin Injection DRUG

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

Difelikefalin Group

Normal Saline (0.9% NaCl) DRUG

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.

Placebo (Normal Saline) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Chittagong Medical College: lead

MeSH Terms

Interventions

difelikefalin; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• PROF. DR. MD NURUL HUDA, FCPS,MD

  Head of the department of nephrology,Chittagong medical college ,Hospital

  STUDY CHAIR

Central Study Contacts

MD SHARIFUL ISLAM SARKER, MBBS

CONTACT

+8801521555223; sobujshariful@gmail.com

DR ZAKWAN ULLAH, MBBS

CONTACT

+8801680560222; sharifulnephrology@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Experimental group: Standard symptomatic treatment for itching + Intravenous difelikefalin

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 13, 2026
• Study Start: April 26, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share