A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
NCT ID: NCT05342623
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
286 participants
INTERVENTIONAL
2022-05-17
2024-02-29
Brief Summary
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Detailed Description
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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 1:1 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 EOT/ET.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Difelikefalin 1 mg Oral Tablet
Patients receive oral difelikefalin 1 mg once daily
Difelikefalin 1 mg Oral Tablet
Difelikefalin 1 mg medication taken orally 1 time/day
Placebo Oral Tablet
Patients receive oral placebo once daily
Placebo Oral Tablet
Placebo tablet taken orally 1 time/day
Interventions
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Difelikefalin 1 mg Oral Tablet
Difelikefalin 1 mg medication taken orally 1 time/day
Placebo Oral Tablet
Placebo tablet taken orally 1 time/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Advanced stage 4 and 5 CKD and end stage renal disease on hemodialysis
* Subject self-reports experiencing at least near-daily (eg, most days of a week) pruritus for at least 6 months prior to screening.
* Inadequate response to current or prior treatments (including emollients/moisturizers, topical medications, or systemic treatments) for pruritus prior to screening.
Prior to randomization on Day 1 of Treatment Period 1:
1. Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and
2. Has a mean baseline WI-NRS score ≥ 5, defined as the average of all non-missing scores reported during the 7-day Run-in Period.
Exclusion Criteria
* Scheduled to receive a renal replacement therapy (dialysis or kidney transplant) during the study.
* Has a concomitant disease, significant medical condition or physical/laboratory/ECG/vital signs abnormality that, in the opinion of the investigator, puts the subject at undue risk or interferes with interpretation of study results, impedes completion of the study procedures, or compromises the validity of the study measurements.
* New or change of treatment received for itch, including antihistamines and corticosteroids (oral, intravenous, or topical), within 14 days prior to the start of run-in.
18 Years
85 Years
ALL
No
Sponsors
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Cara Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cara Therapeutics
Role: STUDY_DIRECTOR
Cara Therapeutics
Locations
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Cara Therapeutics Study Site
Chula Vista, California, United States
Cara Therapeutics Study Site
El Centro, California, United States
Cara Therapeutics Study Site
Huntsville, Alabama, United States
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Phoenix, Arizona, United States
Cara Therapeutics Study Site
Surprise, Arizona, United States
Cara Therapeutics Study Site
Anaheim, California, United States
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Bakersfield, California, United States
Cara Therapeutics Study Site
Beverly Hills, California, United States
Cara Therapeutics Study Site
Garden Grove, California, United States
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La Mesa, California, United States
Cara Therapeutics Study Site
Northridge, California, United States
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Ontario, California, United States
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Riverside, California, United States
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Santa Clara, California, United States
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South Gate, California, United States
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Tarzana, California, United States
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Vacaville, California, United States
Cara Therapeutics Study Site
Valencia, California, United States
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Victorville, California, United States
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Arvada, Colorado, United States
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Denver, Colorado, United States
Cara Therapeutics Study Site
New Haven, Connecticut, United States
Cara Therapeutics Study Site
Atlantis, Florida, United States
Cara Therapeutics Study Site
Cape Coral, Florida, United States
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Coral Gables, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
Cara Therapeutics Study Site
Orange City, Florida, United States
Cara Therapeutics Study Site 2
Orlando, Florida, United States
Cara Therapeutics Study Site
Orlando, Florida, United States
Cara Therapeutics Study Site
Pembroke Pines, Florida, United States
Cara Therapeutics Study Site
Riverview, Florida, United States
Cara Therapeutics Study Site
Tampa, Florida, United States
Cara Therapeutics Study Site
West Palm Beach, Florida, United States
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Albany, Georgia, United States
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East Point, Georgia, United States
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Nampa, Idaho, United States
Cara Therapeutics Study Site
Huntley, Illinois, United States
Cara Therapeutics Study Site
Palos Hills, Illinois, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Zachary, Louisiana, United States
Cara Therapeutics Study Site
Boston, Massachusetts, United States
Cara Therapeutics Study Site
Flint, Michigan, United States
Cara Therapeutics Study Site
Kalamazoo, Michigan, United States
Cara Therapeutics Study Site
Roseville, Michigan, United States
Cara Therapeutics Study Site
Saint Clair, Michigan, United States
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Saint Joseph, Michigan, United States
Cara Therapeutics Study Site
Tupelo, Mississippi, United States
Cara Therapeutics Study Site
Kansas City, Missouri, United States
Cara Therapeutics Study Site
Las Vegas, Nevada, United States
Cara Therapeutics Study Site
Laurelton, New York, United States
Cara Therapeutics Study Site
The Bronx, New York, United States
Cara Therapeutics Study Site
Durham, North Carolina, United States
Cara Therapeutics Study Site
Columbus, Ohio, United States
Cara Therapeutics Study Site
Lima, Ohio, United States
Cara Therapeutics Study Site
Ardmore, Oklahoma, United States
Cara Therapeutics Study Site
Bethlehem, Pennsylvania, United States
Cara Therapeutics Study Site
Upland, Pennsylvania, United States
Cara Therapeutics Study Site
East Providence, Rhode Island, United States
Cara Therapeutics Study Site
Providence, Rhode Island, United States
Cara Therapeutics Study Site
Spartanburg, South Carolina, United States
Cara Therapeutics Study Site
Chattanooga, Tennessee, United States
Cara Therapeutics Study Site
Jackson, Tennessee, United States
Cara Therapeutics Study Site
Knoxville, Tennessee, United States
Cara Therapeutics Study Site
Austin, Texas, United States
Cara Therapeutics Study Sites
Corsicana, Texas, United States
Cara Therapeutics Study Site
El Paso, Texas, United States
Cara Therapeutics Study Site
Greenville, Texas, United States
Cara Therapeutics Study Site
Houston, Texas, United States
Cara Therapeutics Study Site
Houston, Texas, United States
Cara Therapeutics Study Site 2
Houston, Texas, United States
Cara Therapeutics Study Site
Lewisville, Texas, United States
Cara Therapeutics Study Site
McAllen, Texas, United States
Cara Therapeutics Study Site
McKinney, Texas, United States
Cara Therapeutics Study Site
Pasadena, Texas, United States
Cara Therapeutics Study Site
Sherman, Texas, United States
Cara Therapeutics Study Site
Hampton, Virginia, United States
Countries
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References
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Didik S, Golosova D, Xu B, Staruschenko A. Opioids and the Kidney: A Compendium. Kidney360. 2023 Dec 1;4(12):1816-1823. doi: 10.34067/KID.0000000000000291. Epub 2023 Nov 6.
Other Identifiers
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CR845-310301
Identifier Type: -
Identifier Source: org_study_id
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