Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin (NCT05031546) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
Plain-language summary
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Adults ≥ 18 years old;
* Has end-stage renal disease (ESRD) and is currently receiving in-center hemodialysis;
* Has moderate-to-severe pruritus attributed to ESRD which is significantly impacting the patient's quality of life;
* Has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator.
Key Exclusion Criteria:
* Has severe hepatic impairment (Child-Pugh class C), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated;
* Is pregnant or nursing;
* Has been exposed to any other investigational medication in the past 60 days;
* Present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator;
* Has a known or suspected allergy to difelikefalin or any component of the investigational product.