ClinicaliQ Trial Snapshot
- Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus — Recruiting • Phase II • NCT06593392.
- What is being tested: Safety and tolerability of difelikefalin, a novel therapeutic agent, in adolescent patients undergoing haemodialysis who experience moderate-to-severe pruritus (a significant and often treatment-resistant symptom in this population).
- Patient eligibility overview: Adolescents with chronic kidney disease requiring haemodialysis and presenting with moderate-to-severe pruritus; this trial specifically extends evidence from adult populations to the paediatric haemodialysis cohort.
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What This Trial Is Studying
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…
Eligibility Snapshot
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- Participant must be ≥12 to 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. *
- Participant and/or legal guardian (as required) is capable of providing the appropriate signed informed consent and where appropriate, assent.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.