Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03998163
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2019-05-07
Brief Title:
CR845-CLIN3105 A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Sponsor:
Cara Therapeutics Inc
Organization:
Cara Therapeutics Inc
Study Overview
Official Title:
An Open-Label Multicenter Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Status:
COMPLETED
Status Verified Date:
2021-09
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 a multicenter open-label study to evaluate the safety and effectiveness of intravenous IV CR845 at a dose of 05 mcgkg administered after each dialysis session The study includes an up to 12-week Treatment Period
Detailed Description:
Screening Period The Screening Period includes a Screening Visit and a Run-In Period Informed consent will be obtained prior to performing any study-specific procedures The Screening Visit will occur within 21 days prior to the start of the Run-in Period Patients will start the Run-in Period during the week prior to Treatment Period to complete eligibility verification
Treatment Period All scheduled study visits during the Treatment Period will be conducted on dialysis days Patients will be administered CR845 as an IV bolus after the end of their dialysis during a Treatment Period of up to 12 weeks so that each patient will receive CR845 3 times weekly for a total of up to 36 doses End of treatment EOT is defined as the first day of dialysis following the last dose of drug The EOT procedures will be conducted on the dialysis visit following the last dose of study drug
Follow-up Visit A final safety Follow up Visit will be conducted 7-10 days after the EOTEarly Termination Visit
Treatment Period All scheduled study visits during the Treatment Period will be conducted on dialysis days Patients will be administered CR845 as an IV bolus after the end of their dialysis during a Treatment Period of up to 12 weeks so that each patient will receive CR845 3 times weekly for a total of up to 36 doses End of treatment EOT is defined as the first day of dialysis following the last dose of drug The EOT procedures will be conducted on the dialysis visit following the last dose of study drug
Follow-up Visit A final safety Follow up Visit will be conducted 7-10 days after the EOTEarly Termination Visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None