Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Sponsor

Cara Therapeutics, Inc. (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT05031546

Collaborator

(none)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Uremic Pruritus	Drug: Difelikefalin

Detailed 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.

Study Design

Study Type:

Expanded Access

Official Title:

Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.