Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChittagong Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Difelikefalin Injection
Drugntravenous 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)
DrugIntravenous 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.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Difelikefalin GroupExperimental treatment 1 intervention
Group B: Placebo (Normal Saline) GroupPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
Baseline to Week 6Secondary outcomes
1
Change From Baseline in Skindex-10 Score at 6 Weeks
Skindex-10 is a validated questionnaire used to assess quality of life in patients with skin conditions. Scores range from 0 to 60, with higher scores indicating worse quality of life. The outcome will be reported as the mean change from baseline to week 6.
Time frame
Baseline to Week 6Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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