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

Recruiting Phase 2 Interventional Study
Pruritus Chronic Kidney Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
18 (estimated)
Sponsor
Vifor Fresenius Medical Care Renal Pharma · Industry
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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…
Trial Locations
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Eligibility 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 who…
Contacts

Yael Carmeli

+41 058 851 80 00

clinicaltrials@cslbehring.com

CONTACT