Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03636269
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2018-08-03
Brief Title:
CR845-CLIN3103 A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Sponsor:
Cara Therapeutics Inc
Organization:
Cara Therapeutics Inc
Study Overview
Official Title:
A Multicenter Double-blind Randomized Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus With a 52-Week Open Label Extension
Status:
COMPLETED
Status Verified Date:
2022-03
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:
KALM-2
Brief Summary:
This is a multicenter international study to evaluate the safety and efficacy of intravenous IV CR845 at a dose of 05 mcgkg administered after each dialysis session The study includes a 12-week randomized double-blind placebo-controlled Phase and a 52-week Open-label Extension Phase
Detailed Description:
Double-blind Phase The Double-blind Phase of the study will consist of a Screening Visit a 7-day Run-in Period and a 12-week Double-blind Treatment Period Informed consent will be obtained prior to performing any study-specific procedures The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility
Open-label Extension Phase Patients who received at least 30 doses of study drug either active or placebo during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will have the option to receive open label CR845 for an additional 52 weeks
The last dose of open-label study drug will be administered at the last dialysis visit on Week 52 or Early Termination
Follow-up Period A final safety Follow up Visit will be conducted 7-10 days after the End of TreatmentEarly Termination Visit
Open-label Extension Phase Patients who received at least 30 doses of study drug either active or placebo during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will have the option to receive open label CR845 for an additional 52 weeks
The last dose of open-label study drug will be administered at the last dialysis visit on Week 52 or Early Termination
Follow-up Period A final safety Follow up Visit will be conducted 7-10 days after the End of TreatmentEarly 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