An expanded access record providing Difelikefalin in Uremic Pruritus, sponsored by Cara Therapeutics, Inc.. Approved for marketing. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by Cara Therapeutics, Inc. · Expanded access
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.
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.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
Browse Pruritus studies →Cara Therapeutics, Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 5 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
IV Difelikefalin 0.5 mcg/kg administered after each dialysis session (3 times/week)
No study locations are listed for this record.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Cara Therapeutics, Inc.