Ignite Creation Date:
2024-05-06 @ 8:56 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02858726
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2016-07-29
Brief Title:
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:
A Two-Part Multicenter Double-Blind Randomized Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Status:
COMPLETED
Status Verified Date:
2020-07
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:
2 Part Study Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus Patients will receive either CR845 or placebo after each dialysis session for eight weeks The safety and efficacy of CR845 will be monitored throughout the study A sub-group of patients will also have pharmacokinetic assessments completed Part B of the study will assess one dose of IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe itching The dose of CR845 used in Part B will be based on safety and efficacy found in Part A
Detailed Description:
This is a two-part study Patients participating in Part A will be consented and trained on the completion of questionnaires about the severity of itching and overall health Patients will be required to complete questionnaires during their visits to the dialysis center and also while at home on other days Results of the screening questionnaires will assess eligibility for the study Additional laboratory tests and measurements for safety will also be completed during the screening period Patients meeting all criteria for entry into Part A of the study will be randomized to receive either one of three different doses of CR845 or a placebo Patients will receive the study drug for eight weeks IV after each hemodialysis treatment ie 3 times per week Assessments for intensity of itch and safety will also be completed during the 8 week treatment period When patients have completed treatment a Follow-up visit will be completed 7 days later
Patients participating in Part B will be consented and trained on the completion of questionnaires about itching and overall health Patients will be required to complete questionnaires during their visits to the dialysis center and also while at home on other days Laboratory tests and measurements for safety will also be completed during the screening period to determine study eligibility Patients meeting all criteria for entry into Part B of the study will be randomized to receive either CR845 or a placebo The dose of CR845 used will have been determined based on the safety and efficacy from Part A Patients will be dosed with either CR845 or placebo for twelve weeks after each hemodialysis treatment ie 3 times per week Assessments for intensity of itch and safety will be completed during the treatment period also When patients have completed treatment a Follow-up visit will be completed 7 days later
Patients participating in Part B will be consented and trained on the completion of questionnaires about itching and overall health Patients will be required to complete questionnaires during their visits to the dialysis center and also while at home on other days Laboratory tests and measurements for safety will also be completed during the screening period to determine study eligibility Patients meeting all criteria for entry into Part B of the study will be randomized to receive either CR845 or a placebo The dose of CR845 used will have been determined based on the safety and efficacy from Part A Patients will be dosed with either CR845 or placebo for twelve weeks after each hemodialysis treatment ie 3 times per week Assessments for intensity of itch and safety will be completed during the treatment period also When patients have completed treatment a Follow-up visit will be completed 7 days later
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