Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03617536
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2018-07-11
Brief Title:
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease 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 Oral CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Status:
COMPLETED
Status Verified Date:
2024-01
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 double-blind randomized placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease CKD patients with moderate-to-severe pruritus This study will consist of a Screening Period a 7-day Run-in Period a 12 week Treatment Period and a Follow-up Visit approximately 7 days after the last dose of study drug
Detailed Description:
This study will consist of a Screening Period a 7-day Run-in Period a 12 week Treatment Period and a Follow-up Visit approximately 7 to 10 days after the last dose of study drug Informed consent will be obtained prior to performing any study-specific procedures Screening will occur within 7 to 28 days prior to randomization to assess eligibility
If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period they will be randomized in a 1111 ratio to receive orally once daily either placebo or CR845 tablets at doses of 025 05 or 1 mg Randomization will be stratified according to the patients renal disease status moderate CKD severe CKD non-dialysis severe CKD on dialysis ie 3 categories A final safety Follow-up Visit will be conducted 7 to 10 days after the last dose of study drug
If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period they will be randomized in a 1111 ratio to receive orally once daily either placebo or CR845 tablets at doses of 025 05 or 1 mg Randomization will be stratified according to the patients renal disease status moderate CKD severe CKD non-dialysis severe CKD on dialysis ie 3 categories A final safety Follow-up Visit will be conducted 7 to 10 days after the last dose of study drug
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?:
False
Is an FDA AA801 Violation?:
None