Actively Recruiting
An Open-label, Single-arm Study to Evaluate Safety and Tolerability of Intravenous Difelikefalin in Adolescents 12 to 17 Years on Haemodialysis With Moderate-to-Severe Pruritus
Led by Vifor Fresenius Medical Care Renal Pharma · Updated on 2026-05-01
18
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and tolerability of intravenous difelikefalin in adolescents aged 12 to 17 years who are on haemodialysis and suffer from moderate to severe itching related to long-term kidney disease. The study also explores how much difelikefalin enters the bloodstream in this age group. Previous clinical studies have shown difelikefalin to reduce itching in adults on haemodialysis, and this study focuses on assessing its safety in younger patients. Participants will receive difelikefalin intravenously at a dose of 0.5 micrograms per kilogram of dry body weight, administered three times weekly during their haemodialysis sessions for up to 12 weeks. The study includes a screening period lasting up to 4 weeks, which features a 7-day run-in phase before enrollment, followed by the treatment period and a safety follow-up visit 7 to 10 days after treatment ends. The total duration of participation for each adolescent is up to 17 to 18 weeks. During the study, participants will visit the clinic three times per week coinciding with their haemodialysis treatments. Researchers will monitor safety by tracking adverse events throughout the study period, lasting up to 18 weeks. They will also measure difelikefalin blood levels at selected times and explore the effect of the medicine on itching severity and quality of life. Participants will undergo regular assessments and safety follow-up to ensure close monitoring during and shortly after treatment.
CONDITIONS
Brief Title
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be between 12 and less than 18 years of age at the time of consent.
- Participants must have chronic kidney disease on haemodialysis three times weekly for at least 12 weeks before consent.
- Participants must be able to continue haemodialysis without changing its frequency or method.
- Participants must have a mean Worst Itching Numerical Rating Scale (WI-NRS) score greater than 4 during the 7-day run-in period.
- Participants must have had adequate dialysis measured by Kt/V or urea reduction ratio in the last 3 months.
- Prescription dry body weight must be at least 20 kg.
- Men and women must use contraception according to local regulations.
- Participant or legal guardian must provide signed informed consent and assent as appropriate.
You will not qualify if you...
- Known non-compliance with haemodialysis treatments or unlikely to complete the study.
- Planned kidney transplant during the study (being on the transplant list is allowed).
- Itching caused by conditions other than chronic kidney disease or its complications.
- Localized itching limited to the palms.
- Itching only during dialysis sessions.
- Severe liver impairment or hepatic cirrhosis.
- Significant heart failure (e.g., NYHA Class IV).
- Current cancers except completely excised skin cancers.
- Severe mental illness or cognitive impairment affecting study validity.
- Conditions disrupting the blood brain barrier that increase risk.
- Acute or unstable medical conditions increasing risk or interfering with assessments.
- Receiving ongoing ultraviolet B treatment or expecting to during the study.
- Recent changes in itch treatment or prohibited medications within 14 days prior to screening.
- Known allergy to difelikefalin or its components.
- History of substance abuse or excessive alcohol intake within 12 months.
- Participation in another investigational study within 30 days prior to screening.
- Elevated liver enzymes more than three times the upper limit of normal.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including a 7-day run-in period prior to enrollment
Duration - 12 weeks
Participants receive intravenous difelikefalin after each haemodialysis treatment to evaluate safety and tolerability.
Three visits per week during haemodialysis sessions
Duration - 7 to 10 days
Participants are monitored for safety and adverse events after completing treatment.
1 follow-up visit
Trial Site Locations
Total: 14 locations
1
Sichuan University-West China Second University Hospital
Chengdu, China, 610066
Actively Recruiting
2
Guangzhou Women and Children's Medical Center
Guangzhou, China, 510600
Actively Recruiting
3
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, China, 310003
Actively Recruiting
4
The Children's Hospital of Fudan University
Shanghai, China, 201102
Actively Recruiting
5
Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan
Wuhan, China, 430032
Actively Recruiting
6
Pan and Aglaia Kyriakou Children's Hospital
Athens, Greece, 11527
Actively Recruiting
7
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
8
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
Actively Recruiting
9
King Abdullah Specialized Children's Hospital (KASCH)
Riyadh, Saudi Arabia, 14611
Actively Recruiting
10
Hospital Sant Joan de Déu
Barcelona, Spain, " 08950"
Actively Recruiting
11
Hospital Universitario Valle de Hebron
Barcelona, Spain, 8035
Actively Recruiting
12
Jalila Children's Specialty Hospital
Dubai, United Arab Emirates, 25314
Actively Recruiting
13
Royal Hospital for Children Glasgow
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
14
Alder Hey Childrens Hospital
Liverpool, United Kingdom, L14 5AB
Actively Recruiting
Research Team
Y
Yael Carmeli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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