Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-18
SponsorVifor Fresenius Medical Care Renal Pharma
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
1. Participant must be ≥12 to <18 years of age at the time of informed consent.
2. Participants with CKD on HD 3 times weekly for at least 12 weeks prior to the informed consent procedure who can continue HD without changing its frequency or method.
a) WI-NRS scores have been recorded for at least 4 days through a 7-day run-in period.
b) The mean value of the recorded WI-NRS scores is >4.0
Disqualifiers
1. Known to be non-compliant with HD treatments and deemed unlikely by the Investigator to complete the study
2. Planned to receive a kidney transplant during the study. Note: being listed on a kidney transplant list is not an exclusion criterion.
3. Participants with itching caused by conditions other than chronic renal failure or complications of chronic renal failure, which could in the opinion of the Investigator affect the efficacy evaluation (e.g., atopic dermatitis, chronic urticaria).
4. Participants with localised itch restricted to the palms of the hands.
Trial design
Design model
Single group
Treatments tested in this trial
Difelikefalin
DrugThe 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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events (AEs)
To evaluate the safety of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to \<18 years) with moderate-to-severe pruritus
Time frame
Up to 18 weeksSecondary outcomes
1
Pre-dose difelikefalin plasma concentrations (Cpre)
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
Time frame
12 weeks2
Trough difelikefalin plasma concentrations (Ctrough)
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
Time frame
12 Weeks3
Maximum difelikefalin plasma concentrations (Cmax)
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
Time frame
12 WeeksSponsors and contacts
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Source ClinicalTrials.gov