Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03281538
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2017-06-20
Brief Title:
Extension Study to Evaluate IV 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 Extension Study to Evaluate the Long Term Safety of Intravenous CR845 in Hemodialysis Patients With Chronic Kidney Disease-Associated 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 an open-label multicenter long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks
Detailed Description:
This is an open-label multicenter long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks This study will consist of a Screening Visit a 52 week Treatment Period and a Follow-up Visit Informed consent will be obtained prior to performing any study-specific procedures All patients will have a Screening Visit which can be performed anytime within 14 days prior to the first dose of study drug to confirm eligibility
Clinical laboratory tests electrocardiograms ECGs vital signs adverse events and concomitant medications will be monitored throughout the study Blood samples for inflammatory biomarkers will be collected from all patients prior to dialysis on Day 1 and periodically until the End of Treatment or Early Termination Visit Blood samples will also be collected periodically for clinical laboratory tests
Clinical laboratory tests electrocardiograms ECGs vital signs adverse events and concomitant medications will be monitored throughout the study Blood samples for inflammatory biomarkers will be collected from all patients prior to dialysis on Day 1 and periodically until the End of Treatment or Early Termination Visit Blood samples will also be collected periodically for clinical laboratory tests
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