Actively Recruiting
Safety and Tolerability of Difelikefalin in Adolescents 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
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 old at the time of consent.
- Participants must have chronic kidney disease and be on haemodialysis three times weekly for at least 12 weeks before consent.
- Participants must have a mean WI-NRS itching score greater than 4.0 during a 7-day run-in period with at least 4 days recorded.
- Participants must have adequate dialysis adequacy measures (Kt/V or urea reduction ratio) within the last 3 months.
- Participants must have a prescription dry body weight of at least 20 kg.
- Participants and/or guardians must be able to provide informed consent and assent as required.
- Men and women must use contraception according to local regulations during the study.
You will not qualify if you...
- Known non-compliance with haemodialysis treatments or unlikely to complete the study.
- Planned kidney transplant during the study.
- Itching caused by conditions other than chronic renal failure, such as atopic dermatitis or chronic urticaria.
- Itching limited only to the palms of the hands.
- Itching only during dialysis sessions.
- Severe liver disease or cirrhosis.
- Significant heart failure (NYHA Class IV).
- Active malignancy except for completely excised skin cancers.
- Severe mental illness or cognitive impairment affecting study participation.
- Conditions affecting the blood-brain barrier that may increase risk.
- Acute or unstable medical conditions increasing risk or interfering with study.
- Current ultraviolet B treatment or plans to receive it during the study.
- New or changed itch treatments or pain medications within 14 days prior to screening.
- Use of prohibited medications that cannot be stopped 14 days before enrollment.
- Known allergy to difelikefalin or its components.
- History of substance abuse or alcohol intake exceeding set limits.
- Participation in another investigational study within 30 days prior to screening.
- Liver enzyme levels greater than 3 times the upper limit of normal.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here