Trial · Interventional
RecruitingPhase 2Registry dataSafety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Overview
- Status
- Recruiting
- Phase
- Phase 2
- Enrollment
- 18 participants (estimated)
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
7 countries
China, Greece, Israel, Saudi Arabia, Spain, United Arab Emirates, United Kingdom
- Start
- 4 Aug 2026
- Primary completion
- 15 Aug 2029 (estimated)
- Completion
- 15 Aug 2029 (estimated)
- First posted
- 19 Sept 2024
- Last update posted
- 23 Oct 2026
- Conditions
- Pruritus · Chronic Kidney Diseases
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
NCT065933924 Aug 2026 to est. 15 Aug 2029
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Rationale: * People with long term kidney disease who are on haemodialysis (a procedure for removing waste products from the blood) commonly develop a condition that makes their skin very itchy. * Difelikefalin is a medicine that can treat the itching related to long term kidney disease. * Clinical studies have shown difelikefalin to reduce itching in adults on haemodialysis, while being safe and tolerable. * The current study is being done in adolescents aged 12 to 17 years on haemodialysis who have moderate to severe itching related to long term kidney disease to assess if difelikefalin is safe in this age group. The aims of the study are: Main aim: To assess the safety of difelikefalin in adolescents who are on haemodialysis and have itching related to long term kidney disease Secondary aim: To measure the amount of difelikefalin that enters the blood in adolescents who are on haemodialysis and have itching related to long term kidney disease Study Design At least 18 adolescents, aged 12 to 17 years, who are on haemodialysis and have itching related to long term kidney disease will take part in this study. All study participants will receive difelikefalin 3 (or up to 4) times weekly for up to 12 weeks. The study duration for a participant is up to 17 to 18 weeks; during this period, participants will visit the clinic 3 times weekly (during their haemodialysis visits).
Interventions
- DifelikefalinDrug
Arms1
Experimental
Single arm
Primary outcomes1
Outcomes the sponsor listed as primary.
Incidence of adverse events (AEs)
Time frame · Up to 18 weeks
Registry description
To evaluate the safety of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to \<18 years) with moderate-to-severe pruritus
Secondary outcomes(3)
Pre-dose difelikefalin plasma concentrations (Cpre)
Time frame · 12 weeks
Registry description
To evaluate difelikefalin plasma concentrations after multiple administrations of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to \<18 years) with moderate-to-severe pruritus
Trough difelikefalin plasma concentrations (Ctrough)
Time frame · 12 Weeks
Registry description
To evaluate difelikefalin plasma concentrations after multiple administrations of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to \<18 years) with moderate-to-severe pruritus
Maximum difelikefalin plasma concentrations (Cmax)
Time frame · 12 Weeks
Registry description
To evaluate difelikefalin plasma concentrations after multiple administrations of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to \<18 years) with moderate-to-severe pruritus
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 12 Years up to 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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