RecruitingPhase 2NCT06593392

Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus

KOR-PED-202 An Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis With Moderate-to-Severe Pruritus


Sponsor

Vifor Fresenius Medical Care Renal Pharma

Enrollment

18 participants

Start Date

May 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and tolerability of a drug called difelikefalin in teenagers on dialysis who suffer from moderate to severe itching (a very common and distressing problem in kidney disease). **You may be eligible if...** - You are between 12 and 17 years old - You have kidney disease and are on dialysis 3 times per week for at least 12 weeks - You experience significant itching (average score above 4 out of 10 on a 7-day check-in) - Your dialysis is working well enough based on recent lab tests - You weigh at least 20 kg (about 44 lbs) **You may NOT be eligible if...** - You are expected to receive a kidney transplant during the study - You are known to regularly miss dialysis sessions - You have certain serious medical conditions that might interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDifelikefalin

The study includes a screening period of up to 4 weeks (including a 7-day run-in period during the week prior to enrolment), a study treatment period of 12 weeks, and a safety follow-up visit at 7 (up to 10) days after EoT. Total study duration for a single participant is up to 17 to 18 weeks.


Locations(14)

Sichuan University-West China Second University Hospital

Chengdu, China

Guangzhou Women and Children's Medical Center

Guangzhou, China

The Children's Hospital Zhejiang University School of Medicine

Hangzhou, China

The Children's Hospital of Fudan University

Shanghai, China

Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan

Wuhan, China

Pan and Aglaia Kyriakou Children's Hospital

Athens, Greece

Shaare Zedek Medical Center

Jerusalem, Israel

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

King Abdullah Specialized Children's Hospital (KASCH)

Riyadh, Saudi Arabia

Hospital Sant Joan de Déu

Barcelona, Spain

Hospital Universitario Valle de Hebron

Barcelona, Spain

Jalila Children's Specialty Hospital

Dubai, United Arab Emirates

Royal Hospital for Children Glasgow

Glasgow, United Kingdom

Alder Hey Childrens Hospital

Liverpool, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06593392


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