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Tests treatment safety and results for Pruritus
Official title Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
ClinicalTrials.gov ID: NCT06593392
What this study is testing
What is Difelikefalin?
Difelikefalin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for pruritus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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).
See the full eligibility 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.
- 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 how well it works evaluation...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, China
- Guangzhou, China
- Hangzhou, China
- Shanghai, China
- Wuhan, China
- Athens, Greece
- Jerusalem, Israel
- Petah Tikva, Israel
- Riyadh, Saudi Arabia
- Barcelona, Spain
- Dubai, United Arab Emirates
- Glasgow, United Kingdom
- Liverpool, United Kingdom
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 study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, China; Guangzhou, China; Hangzhou, China; Shanghai, China; Wuhan, China; Athens, Greece and 7 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.