Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Uremic Pruritus Clinical Trial

Official title:

Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT05031546
• Other study ID #: CR845-500301
• Status: Approved for marketing

Study information

• Verified date: May 2022
• Source: Cara Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Description:

Visits during the expanded access program will consist of a Baseline Visit to confirm eligibility and an End of Treatment visit. Patients will receive IV difelikefalin at a dose of 0.5 mcg/kg after each dialysis session, generally 3 times per week. The End of Treatment visit will be defined as the first dialysis visit following the last dose of IV difelikefalin under the intermediate-size patient population expanded access protocol.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

Intervention

Drug:
• Difelikefalin
IV Difelikefalin 0.5 mcg/kg administered after each dialysis session (3 times/week)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cara Therapeutics, Inc.