Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05342623
Status:
TERMINATED
Last Update Posted:
2024-05-07
First Post:
2022-04-18
Brief Title:
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Sponsor:
Cara Therapeutics Inc
Organization:
Cara Therapeutics Inc
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled 12-Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects With Moderate-to-Severe Pruritus With an up to 52-Week Long-term Extension
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Corporate decision to discontinue work in advanced chronic kidney disease
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 oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in advanced chronic kidney disease CKD patients with moderate-to-severe pruritus This study is comprised of an Efficacy Assessment Phase and a Long-term Extension Phase The Efficacy Assessment Phase includes a double-blind 12-week Treatment Period Treatment Period 1 and the Long-term Extension Phase includes a double-blind Treatment Period Treatment Period 2 of up to 52 weeks
Detailed Description:
This study will consist of a Screening Period a 7-day Run-in Period a 12 week double-blind Efficacy Assessment Phase Treatment Period 1 a double-blind Long-term Extension Phase Treatment Period 2 of up to 52 weeks and a Follow-up Visit 7 to 10 days after the End of Treatment EOTEarly Termination ET Visit
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 11 ratio to receive once daily oral difelikefalin tablets at a dose of 1 mg or placebo for 12 weeks Subjects will be stratified according to their use or nonuse of medications to treat pruritus prior to randomization as well as the presence or absence of specific medical conditions During the Long-term Extension Phase patients will be re-randomized on Day 1 of Treatment Period 2 to receive either oral difelikefalin 1 mg or placebo once daily for up to an additional 52 weeks A final safety Follow-up Visit will be conducted 7 to 10 days after the EOTET
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 11 ratio to receive once daily oral difelikefalin tablets at a dose of 1 mg or placebo for 12 weeks Subjects will be stratified according to their use or nonuse of medications to treat pruritus prior to randomization as well as the presence or absence of specific medical conditions During the Long-term Extension Phase patients will be re-randomized on Day 1 of Treatment Period 2 to receive either oral difelikefalin 1 mg or placebo once daily for up to an additional 52 weeks A final safety Follow-up Visit will be conducted 7 to 10 days after the EOTET
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
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