Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02229929
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2014-08-27
Brief Title:
Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients and Its Efficacy in Patients With Uremic Pruritus
Sponsor:
Cara Therapeutics Inc
Organization:
Cara Therapeutics Inc
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Intravenous CR845 in Hemodialysis Patients and Its Safety and Efficacy in Hemodialysis Patients With Uremic Pruritus
Status:
COMPLETED
Status Verified Date:
2016-08
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:
The primary purpose of this study is to
Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week in patients who are undergoing hemodialysis Part A
This study is also investigating whether repeated doses of IV CR845 over two weeks is safe and effective in reducing the intensity of itching in hemodialysis patients with uremic pruritus Part B
Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week in patients who are undergoing hemodialysis Part A
This study is also investigating whether repeated doses of IV CR845 over two weeks is safe and effective in reducing the intensity of itching in hemodialysis patients with uremic pruritus Part B
Detailed Description:
Placebo-controlled
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