Safety and Tolerability of Difelikefalin in Adolescents on HD with Moderate-to-Severe Pruritus
Research type
Research Study
Full title
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
IRAS ID
1010159
Contact name
David Beintema
Contact email
Sponsor organisation
Vifor Fresenius Medical Care Renal Pharma Ltd.
Research summary
Chronic Kidney Disease-associated Pruritus (CKD-aP) is a distressing medical condition characterised by very itchy skin that has a significant negative impact on quality of life. CKD-aP is very common in people on haemodialysis (HD). There are treatments approved for adults with the condition, such as difelikefalin, however, no treatments are currently approved for young people.
Difelikefalin is a new drug that binds to specific receptors on the surface of certain cells outside of the brain. This binding activates the receptor and triggers a chemical reaction that works to reduce the itch sensation.
Difelikefalin will be tested in Study KOR-PED-202 to check if it is well-tolerated and safe in young people aged 12-17 with CKD-aP who are receiving HD. The study is also designed to learn more about how the drug is processed by the body and to get an idea if it is effective against CKD-aP in young people.
Study KOR-PED-202 consists of 3 parts: screening, treatment and follow-up. Patients who wish to participate in the study will have some tests first during the 4-week long screening period to see if the study is right for them. Participants who pass the screening will enter the treatment period to receive difelikefalin 3 times a week for 12 weeks after their normal dialysis sessions at the hospital. Difelikefalin will be given as an injection into a vein, where possible through the lines used for participants’ HD treatment. Participants who complete the treatment period will have an end of treatment visit and a follow-up visit and weeks 13 and 14.
The assessments for Study KOR-PED-202 include evaluation of medical history and use of other medications, documenting of any side effects, physical examinations, vital signs, ECGs, blood tests including blood pregnancy tests in females who can have children, and questionnaires.
Study KOR-PED-202 will run at around 25 sites worldwide with around 3 sites in the UK.REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0084
Date of REC Opinion
25 Sep 2024
REC opinion
Further Information Favourable Opinion