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Looking for participantsPhase2

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

Sponsor: Vifor Fresenius Medical Care Renal Pharma

NCT ID: NCT06593392

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Difelikefalin (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Difelikefalin — drug: 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.
Patient visit burden
Not specified by the sponsor

In plain English

This study is looking at how safe and tolerable difelikefalin is for young people aged 12 to under 18 who have moderate-to-severe itching linked to chronic kidney disease while on haemodialysis. Haemodialysis is a treatment that filters the blood, and it is done three times a week in this study.

Who can take part

  • Aged 12 to under 18 when consenting
  • Has chronic kidney disease and has been on haemodialysis three times a week for at least 12 weeks, and can keep the same dialysis routine
  • Has moderate-to-severe itching, shown by an average itching score above 4.0 recorded on at least 4 days over a 7-day run-in period
  • Has had dialysis quality checks in the last 3 months (Kt/V or urea reduction ratio measurements) that meet the study's standards
  • Has a prescribed dry body weight of at least 20 kg
  • Uses contraception in line with local rules for clinical studies, if applicable
  • The young person and/or their legal guardian can give informed consent where needed

Who may not be able to

  • Known not to keep up with haemodialysis treatments, or unlikely to finish the study
  • Planned kidney transplant during the study (being on the transplant waiting list is fine)
  • Itching caused by something other than kidney failure, such as atopic dermatitis or long-term hives
  • Itching only on the palms of the hands, or only during dialysis sessions
  • Severe liver problems such as cirrhosis or Child-Pugh Class C liver disease
  • Severe heart failure (for example, New York Heart Association Class IV)
  • Current cancer, apart from fully removed skin cancers or fully removed carcinoma in situ
  • Severe mental illness, dementia or other mental health problems that could affect study measurements
  • Conditions that seriously affect the blood-brain barrier, such as brain tumours, cancer spread to the brain, active multiple sclerosis or advanced Alzheimer's disease
  • An urgent or unstable medical condition that could raise risk or interfere with the study
  • Ongoing ultraviolet B light treatment expected to continue during the study
  • New or changed itch treatments (including antihistamines and steroid tablets, injections or creams) within 14 days before screening
  • New or changed prescriptions for opioids, gabapentin or pregabalin within 14 days before screening
  • Taking certain banned medicines (for example, nalfurafine hydrochloride or opioid antagonists) that cannot be stopped at least 14 days before joining
  • Known allergy to difelikefalin or any of its ingredients
  • History of alcohol, drug or substance misuse within 12 months before screening, or regularly drinking more than two units of alcohol a day more than once a week
  • Took part in another research study of a drug or device within 30 days before screening, or is currently taking another investigational treatment
  • Liver blood test results (ALT or AST) more than three times the upper limit of normal

What taking part involves

  • • The study medicine is difelikefalin — not stated how it is given or how long for; ask the trial team

Time commitment: Not stated — ask the trial team about visit schedules, study length and what taking part involves beyond continuing usual haemodialysis three times a week.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
12 Years to 18 Years
Who
All
Number of participants
18
Started
2026-08-04
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for pruritus
  • • Phase2 - 18 participants
  • • 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

Who can take part?

  • • Ages 12 Years to 18 Years
  • • Diagnosed with pruritus

Where?

  • • Glasgow - Royal Hospital for Children Glasgow
  • • Liverpool - Alder Hey Childrens Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

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).

More detail

The purpose of this study is to evaluate the safety and tolerability, as assessed by incidence of AEs, of 0.5 μg/kg IV difelikefalin in adolescent participants on HD (3 times weekly) with moderate-to-severe pruritus over 12 weeks. Additionally, difelikefalin plasma concentrations (Cmax and Ctrough) after multiple administrations will be evaluated at a few selected time points and the efficacy of difelikefalin in improving itching and health-related QoL will be investigated as exploratory. Study details include: * The study duration for a single participant will be up to 17 to 18 weeks. * The treatment duration for each participant will be up to 12 weeks. * The visit frequency will be 3 times weekly (during HD visits). Trial Population: Participants in this study must: * Be male or female adolescent participants ≥12 to \<18 years of age at the time of informed consent/assent * Have CKD-aP on HD (at least 3 hours in duration 3 times weekly, for at least 12 weeks prior to the informed consent procedure) * Be able to continue HD without changing its frequency or method * Have a mean value WI-NRS score during the run-in period of \>4.0 (moderate-to-severe pruritus) Participants in this study must not: * Be planned to receive a kidney transplant during the study * Have known severe hepatic impairment (e.g., Child-Pugh Class C) or concurrent hepatic cirrhosis, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the reference upper limit of normal (ULN), significant systolic or diastolic heart failure, or concurrent malignancy (except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely) Number of Participants: At least 18 participants evaluable for the primary safety endpoint will be enrolled in the study. Note: Enrolled means participants, or their legally acceptable representatives, agreement to participate in a clinical study following completion of the informed consent process and screening. A participant will only be considered enrolled if the informed consent/assent is not withdrawn prior to participating in any study activity after screening including the run-in period. Study Arms and Duration: * This is a single-arm, open-label study. All participants will receive IV difelikefalin at a dose of 0.5 μg/kg of dry body weight after each HD treatment 3 times weekly for 12 weeks. * 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 follow-up period of 7 (up to 10) days. * If for any reason difelikefalin is interrupted for more than 1 week, the participant should be withdrawn from the study intervention.

PruritusChronic Kidney Diseases

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years - 18 Years
  • Who can join: All genders

What the study is looking for

  • ✓1\. Participant must be ≥12 to \<18 years of age at the time of agreement to take part.
  • ✓2\. Participants with CKD on HD 3 times weekly for at least 12 weeks prior to the agreement to take part procedure who can...
  • ✓3\. Participants whose WI-NRS score in the 7-day run-in period (meets both of the below:
  • ✓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

Who cannot take part

  • ✗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...
  • ✗4\. Participants with localised itch restricted to the palms of the hands.
  • ✗5\. Participants with pruritus only during the dialysis session (by participant report).
  • ✗6\. Participants with known concurrent liver cirrhosis or severe liver impairment (e.g., Child-Pugh Class C).
See the full criteria
Inclusion Criteria: * 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. * 3\. Participants whose WI-NRS score in the 7-day run-in period (meets both of the below: * 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 * 4\. Over the last 3 months prior to screening, the participant has had at least 1 of the following: * a) At least 2 single-pool Kt/V measurements ≥1.2 on different dialysis days * b) At least 2 urea reduction ratio measurements ≥65% on different dialysis days * c) 1 single-pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis day * 5\. Prescription dry body weight ≥20 kg * 6\. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * 7\. Participant and/or legal guardian (as required) is capable of providing the appropriate signed informed consent and where appropriate, assent. Exclusion Criteria: * 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. * 5\. Participants with pruritus only during the dialysis session (by participant report). * 6\. Participants with known concurrent hepatic cirrhosis or severe hepatic impairment (e.g., Child-Pugh Class C). * 7\. Significant systolic or diastolic heart failure (e.g., New York Heart Association Class IV congestive heart failure). * 8\. Participants with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely. * 9\. Severe mental illness or cognitive impairment (e.g., dementia) or other concurrent mental disorder that, in the opinion of the Investigator, would compromise the validity of study measurements. * 10\. Conditions associated with clinically important disruptions to the blood brain barrier (for example, primary brain malignancies, CNS metastases or other inflammatory conditions, active multiple sclerosis, advanced Alzheimer's disease) that in the Investigator's opinion may be associated with unacceptable risk for CNS effects. * 11\. Acute or unstable medical condition(s) that in the Investigator's opinion, may be associated with increased risk to the participant, or may interfere with study assessments, outcomes, or the ability to provide written informed consent or comply with study procedures. * 12\. Participant is receiving ongoing ultraviolet B treatment and anticipates receiving such treatment during the study. * 13\. New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening. * 14\. New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening. * 15\. Participant is receiving prohibited medication (e.g., nalfurafine hydrochloride, opioid antagonists) that cannot be stopped at least 14 days before enrolment in the study. * 16\. Participant has known hypersensitivity to the study intervention or any components of the difelikefalin formulation. * 17\. Known or suspected history of alcohol, narcotic, or other drug abuse or substance dependence within 12 months prior to screening or participant with any alcoholic beverage intake of more than two units per day more than once per week. * 18\. Participation in any other investigational device or drug study \<30 days prior to screening, or current treatment with other investigational agent(s). * 19\. Serum ALT, AST greater than 3× the reference ULN.

Where Is This Study? (2 UK sites)

Royal Hospital for Children Glasgow

Glasgow G51 4TF, United Kingdom

Recruiting

Alder Hey Childrens Hospital

Liverpool L14 5AB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Kelly Davies

research@alderhey.nhs.uk0151 2525570

How to Get in Touch

Yael Carmeli

Sponsor contact

CONTACT

+41 058 851 80 00 clinicaltrials@cslbehring.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08