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A study to test if difelikefalin is safe in adolescents with itching related to long term kidney disease
EU CTIS ID: 2023-509909-74-00
What this study is testing
To evaluate the safety of 0.5 μg/kg difelikefalin in HD adolescents (≥12 to <18 years) with moderate-to-severe pruritus.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be ≥12 to <18 years of age at the time of informed consent.
- 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.
- Participants whose WI-NRS score in the 7-day run-in period (meets both of the below: WI-NRS scores have been recorded for at least 4 days through a 7-day run-in period. The mean value of the recorded WI-NRS scores is >4.0
- Over the last 3 months prior to screening, the participant has had at least 1 of the following: At least 2 single-pool Kt/V measurements ≥1.2 on different dialysis days At least 2 urea reduction ratio measurements ≥65% on different dialysis days 1 single-pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis day
- Prescription dry body weight ≥20 kg
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
You likely can't join if
- Known to be non-compliant with HD treatments and deemed unlikely by the Investigator to complete the study
- 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.
- 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.
- Participant is receiving ongoing ultraviolet B treatment and anticipates receiving such treatment during the study.
- New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening.
- New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening.
See the full eligibility criteria
Who can join
- Participant must be ≥12 to <18 years of age at the time of informed consent.
- 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.
- Participants whose WI-NRS score in the 7-day run-in period (meets both of the below: WI-NRS scores have been recorded for at least 4 days through a 7-day run-in period. The mean value of the recorded WI-NRS scores is >4.0
- Over the last 3 months prior to screening, the participant has had at least 1 of the following: At least 2 single-pool Kt/V measurements ≥1.2 on different dialysis days At least 2 urea reduction ratio measurements ≥65% on different dialysis days 1 single-pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis day
- Prescription dry body weight ≥20 kg
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participant and/or legal guardian (as required) is capable of providing the appropriate signed informed consent and where appropriate, assent.
What rules you out
- Known to be non-compliant with HD treatments and deemed unlikely by the Investigator to complete the study
- 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.
- 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.
- Participant is receiving ongoing ultraviolet B treatment and anticipates receiving such treatment during the study.
- New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening.
- New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening.
- Participant is receiving prohibited medication (e.g., nalfurafine hydrochloride, opioid antagonists) that cannot be stopped at least 14 days before enrolment in the study.
- Participant has known hypersensitivity to the study intervention or any components of the difelikefalin formulation.
- 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.
- Participation in any other investigational device or drug study <30 days prior to screening, or current treatment with other investigational agent(s).
- Serum ALT, AST greater than 3× the reference ULN.
- Planned to receive a kidney transplant during the study. Note: being listed on a kidney transplant list is not an exclusion criterion.
- 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).
- Participants with localised itch restricted to the palms of the hands.
- Participants with pruritus only during the dialysis session (by participant report).
- Participants with known concurrent hepatic cirrhosis or severe hepatic impairment (e.g., Child-Pugh Class C).
- Significant systolic or diastolic heart failure (e.g., New York Heart Association Class IV congestive heart failure).
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- China
- Saudi Arabia
- United Arab Emirates
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; China; Saudi Arabia; United Arab Emirates; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.