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.
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