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Clinical Trial Details

Trial ID: L0114
Source ID: NCT05342623
Associated Drug: Difelikefalin 1 Mg Oral Tablet
Title: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Pruritus
Interventions: DRUG: Difelikefalin 1 mg Oral Tablet|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS score at Week 12 of Treatment Period 1, Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable"., Week 12 of Treatment Period 1 | Secondary: Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the WI-NRS at Week 8 of Treatment Period 1., Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable"., Week 8 of Treatment Period 1|Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the WI-NRS at Week 4 of Treatment Period 1., Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable"., Week 4 of Treatment Period 1|Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects who are "complete itch responders" defined as subjects with ≥ 70% of the non-missing 24-hour WI-NRS scores equal to 0 or 1 at Week 12 of Treatment Period 1., Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable"., Week 12 of Treatment Period 1|Efficacy Assessment Phase (Treatment Period 1): Change from baseline in Sleep Quality Questionnaire score at the end of Week 12 of Treatment Period 1., Sleep Quality will be measured using an NRS used to indicate how much itch has interfered with sleep during the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "did not interfere" and "10" represents "completely interfered"., Week 12 of Treatment Period 1
Sponsor/Collaborators: Sponsor: Cara Therapeutics, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 286
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-05-17
Completion Date: 2024-02-29
Results First Posted:
Last Update Posted: 2024-05-07
Locations: Cara Therapeutics Study Site, Huntsville, Alabama, 35805, United States|Cara Therapeutics Study Site, Phoenix, Arizona, 85016, United States|Cara Therapeutics Study Site, Surprise, Arizona, 85374, United States|Cara Therapeutics Study Site, Anaheim, California, 92801, United States|Cara Therapeutics Study Site, Bakersfield, California, 93308, United States|Cara Therapeutics Study Site, Beverly Hills, California, 90211, United States|Cara Therapeutics Study Site, Chula Vista, California, 91910, United States|Cara Therapeutics Study Site, El Centro, California, 92243, United States|Cara Therapeutics Study Site, Garden Grove, California, 92844, United States|Cara Therapeutics Study Site, La Mesa, California, 91942, United States|Cara Therapeutics Study Site, Northridge, California, 91324, United States|Cara Therapeutics Study Site, Ontario, California, 91762, United States|Cara Therapeutics Study Site, Riverside, California, 92505, United States|Cara Therapeutics Study Site, S. Gate, California, 90280, United States|Cara Therapeutics Study Site, Santa Clara, California, 91351, United States|Cara Therapeutics Study Site, Tarzana, California, 91356, United States|Cara Therapeutics Study Site, Vacaville, California, 95687, United States|Cara Therapeutics Study Site, Valencia, California, 91355, United States|Cara Therapeutics Study Site, Victorville, California, 92392, United States|Cara Therapeutics Study Site, Arvada, Colorado, 80002, United States|Cara Therapeutics Study Site, Denver, Colorado, 80230, United States|Cara Therapeutics Study Site, New Haven, Connecticut, 06511, United States|Cara Therapeutics Study Site, Atlantis, Florida, 33462, United States|Cara Therapeutics Study Site, Cape Coral, Florida, 33914, United States|Cara Therapeutics Study Site, Coral Gables, Florida, 33134, United States|Cara Therapeutics Study Site, Fort Lauderdale, Florida, 33308, United States|Cara Therapeutics Study Site, Hialeah, Florida, 33010, United States|Cara Therapeutics Study Site, Miami, Florida, 33143, United States|Cara Therapeutics Study Site, Miami, Florida, 33173, United States|Cara Therapeutics Study Site, Orange City, Florida, 32763, United States|Cara Therapeutics Study Site 2, Orlando, Florida, 32806, United States|Cara Therapeutics Study Site, Orlando, Florida, 32808, United States|Cara Therapeutics Study Site, Pembroke Pines, Florida, 33024, United States|Cara Therapeutics Study Site, Riverview, Florida, 33578, United States|Cara Therapeutics Study Site, Tampa, Florida, 33603, United States|Cara Therapeutics Study Site, West Palm Beach, Florida, 33401, United States|Cara Therapeutics Study Site, Albany, Georgia, 31701, United States|Cara Therapeutics Study Site, East Point, Georgia, 30344, United States|Cara Therapeutics Study Site, Nampa, Idaho, 83687, United States|Cara Therapeutics Study Site, Huntley, Illinois, 60142, United States|Cara Therapeutics Study Site, Palos Hills, Illinois, 60465, United States|Cara Therapeutics Study Site, Kansas City, Kansas, 48504, United States|Cara Therapeutics Study Site, Louisville, Kentucky, 40205, United States|Cara Therapeutics Study Site, Baton Rouge, Louisiana, 70808, United States|Cara Therapeutics Study Site, Metairie, Louisiana, 70006, United States|Cara Therapeutics Study Site, Shreveport, Louisiana, 71101, United States|Cara Therapeutics Study Site, Zachary, Louisiana, 70791, United States|Cara Therapeutics Study Site, Boston, Massachusetts, 02111, United States|Cara Therapeutics Study Site, Flint, Michigan, 48504, United States|Cara Therapeutics Study Site, Kalamazoo, Michigan, 49007, United States|Cara Therapeutics Study Site, Roseville, Michigan, 48066, United States|Cara Therapeutics Study Site, Saint Clair, Michigan, 48081, United States|Cara Therapeutics Study Site, Saint Joseph, Michigan, 49085, United States|Cara Therapeutics Study Site, Tupelo, Mississippi, 38801, United States|Cara Therapeutics Study Site, Kansas City, Missouri, 64131, United States|Cara Therapeutics Study Site, Las Vegas, Nevada, 89128, United States|Cara Therapeutics Study Site, Bronx, New York, 10455, United States|Cara Therapeutics Study Site, Laurelton, New York, 11413, United States|Cara Therapeutics Study Site, Durham, North Carolina, 27704, United States|Cara Therapeutics Study Site, Columbus, Ohio, 43215, United States|Cara Therapeutics Study Site, Lima, Ohio, 45805, United States|Cara Therapeutics Study Site, Ardmore, Oklahoma, 73401, United States|Cara Therapeutics Study Site, Bethlehem, Pennsylvania, 18107, United States|Cara Therapeutics Study Site, Upland, Pennsylvania, 19013, United States|Cara Therapeutics Study Site, East Providence, Rhode Island, 02914, United States|Cara Therapeutics Study Site, Providence, Rhode Island, 02904, United States|Cara Therapeutics Study Site, Spartanburg, South Carolina, 29302, United States|Cara Therapeutics Study Site, Chattanooga, Tennessee, 37404, United States|Cara Therapeutics Study Site, Jackson, Tennessee, 38305, United States|Cara Therapeutics Study Site, Knoxville, Tennessee, 37924, United States|Cara Therapeutics Study Site, Austin, Texas, 78751, United States|Cara Therapeutics Study Sites, Corsicana, Texas, 75110, United States|Cara Therapeutics Study Site, El Paso, Texas, 79902, United States|Cara Therapeutics Study Site, Greenville, Texas, 75402, United States|Cara Therapeutics Study Site, Houston, Texas, 77079, United States|Cara Therapeutics Study Site, Houston, Texas, 77081, United States|Cara Therapeutics Study Site 2, Houston, Texas, 77099, United States|Cara Therapeutics Study Site, Lewisville, Texas, 75057, United States|Cara Therapeutics Study Site, McAllen, Texas, 78503, United States|Cara Therapeutics Study Site, McKinney, Texas, 75069, United States|Cara Therapeutics Study Site, Pasadena, Texas, 77504, United States|Cara Therapeutics Study Site, Sherman, Texas, 75090, United States|Cara Therapeutics Study Site, Hampton, Virginia, 23666, United States
URL: https://clinicaltrials.gov/show/NCT05342623

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress