Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05031546
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2022-05-18
First Post:
2021-08-26
Brief Title:
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
Sponsor:
Cara Therapeutics Inc
Organization:
Cara Therapeutics Inc
Study Overview
Official Title:
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 05 mcgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None