Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

NCT05031546 | Unknown

• 1 other identifier: CR845-500301
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Uremic Pruritus

Keywords

Hemodialysis; Pruritus; Uremic Pruritus; Dialysis; CR845; Difelikefalin; Chronic Itch; CKD; CKD-associated pruritus; CKD-aP; ESRD (end stage renal disease); Itch; Itching; KALM; Chronic Kidney Disease; Kidney failure, chronic; Kidney dysfunction; Generalized pruritus; Expanded access; Compassionate use

Interventions

Difelikefalin DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cara Therapeutics, Inc.: lead

MeSH Terms

Conditions

Pruritus; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

difelikefalin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05