Study to improve uremic pruritus

JRCT ID: jRCT1041240033

Registered date:24/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Uremic pruritus
• Date of first enrollment: 24/05/2024
• Target sample size: 60
• Countries of recruitment: none,Japan
• Study type: Interventional

Intervention(s)

Control drug group: Nalfurafine hydrochloride 2.5 mcg/day before bedtime
Study drug group: Difelikefalin acetate 0.5 mcg/kg/dose, intravenous injection, 3 doses per week at the end of dialysis

Outcome(s)

• Primary Outcome: The primary endpoint for the efficacy analysis focused on the change in pruritus Visual Analog Scale (VAS) score from baseline to 4 weeks after the initiation of drug administration.

Secondary Outcome

The following six items will be evaluated as secondary endpoints.
1) Change from baseline DLQI in DLQI measured at 1, 2, 3, and 4 weeks after starting the assigned drug
2) Change from baseline ESS in ESS measured at 1 week, 2 weeks, 3 weeks, and 4 weeks after starting assigned drug
3) Change from baseline ISI in ISI measured at 2 and 4 weeks after starting assigned drug
4) Change from baseline PAC-QOL in PAQ-QOL measured at 2 and 4 weeks after starting assigned drug
5) Adverse events up to the final observation point (5 weeks after the start of the study)
6) Percentage of patients continuing to use the assigned drug at the final observation point (5 weeks after the start of the study) (=number of patients continuing to use the assigned drug at the final observation point/number of patients at the time of assignment to the assigned drug group)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Individuals undergoing chronic maintenance hemodialysis, receiving the procedure three times weekly.
2) Age criterion: 20 years or older.
3) Uremic pruritus patients exhibiting a pruritus Visual Analog Scale (VAS) score of 15 mm or higher within the preceding 24 hours.
4) Patients for whom general drug treatments, excluding KOR agonists, for dialysis-related pruritus, where conventional measures (moisturizers, steroids, antihistamines, antiallergic drugs) have proven insufficiently efficacious.
5) Patients must possess the cognitive capacity to provide consent and articulate their intentions.
6) Patients for whom freely given written consent subsequent to comprehensive informed consent discussions regarding their participation in the study has been obtained.

Exclude criteria

1) Individuals unable to independently complete Visual Analog Scale (VAS) and questionnaires (DLQI, ESS, ISI, PAC-QOL).
2) Cases where the etiology of uremic pruritus is definitively attributed to factors other than chronic kidney disease, such as dermatological conditions causing pruritus or cholestatic liver disease.
3) History of KOR agonist (difelikefalin acetate or nalfurafine hydrochloride) or other opioid drug usage within the 28 days preceding baseline measurement.
4) Commencement of new prescriptions or alterations in the dosage of uremic pruritus drug treatments (topical or oral, e.g., moisturizers, steroids, antihistamines, antiallergic drugs) within the 28 days prior to baseline measurement.
5) Patients with a documented history of opioid allergies.
6) Pregnant or breastfeeding individuals.
7) Individuals with severe liver damage classified as Child-Pugh grade C.
8) Individuals deemed unsuitable for participation in the research as determined by the principal investigator or sub-research physician.

Related Information

• Primary Sponsor: Fujimoto Keiji