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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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05031546
Study type Expanded Access
Source Cara Therapeutics, Inc.
Contact
Status Approved for marketing
Phase
View Details
See also
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