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Clinical Trial Details

Trial ID: L0115
Source ID: NCT05356403
Associated Drug: Difelikefalin 1 Mg Oral Tablet
Title: CR845-310302: 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: 105
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-26
Completion Date: 2024-02-26
Results First Posted:
Last Update Posted: 2024-05-07
Locations: Cara Therapeutics Study Site, Northridge, California, 91324, United States|Cara Therapeutics Study Site, Miami Lakes, Florida, 33014, United States|Cara Therapeutics Study Site, Miami Lakes, Florida, 33016, United States|Cara Therapeutics Study Site, Miami, Florida, 33032, United States|Cara Therapeutics Study Site, Weston, Florida, 33331, United States|Cara Therapeutics Study Site, Brunswick, Georgia, 31520, United States|Cara Therapeutics Study Site, New York, New York, 10016, United States|Cara Therapeutics Study Site, Orangeburg, South Carolina, 29118, United States|Cara Therapeutics Study Site, Sugar Land, Texas, 77476, United States|Cara Therapeutics Study Site, Ciudad Autonoma de Buenos Aire, C1425DES, Argentina|Cara Therapeutics Study Site, Corrientes, W3400AMZ, Argentina|Cara Therapeutics Study Site, Lanús, B1824KAJ, Argentina|Cara Therapeutics Study Site, Mar Del Plata, Argentina|Cara Therapeutics Study Site, San Nicolás, 2900, Argentina|Cara Therapeutics Study Site, Sarandí, 1872, Argentina|Cara Therapeutics Study Site, Adelaide, Australia|Cara Therapeutics Study Site, Camperdown, Australia|Cara Therapeutics Study Site, Concord, Australia|Cara Therapeutics Study Site, Gosford, Australia|Cara Therapeutics Study Site, Kogarah, Australia|Cara Therapeutics Study Site, Launceston, Australia|Cara Therapeutics Study Site, Liverpool, Australia|Cara Therapeutics Study Site, Melbourne, Australia|Cara Therapeutics Study Site, Saint Albans, Australia|Cara Therapeutics Study Site, Westmead, Australia|Cara Therapeutics Study Site, Belo Horizonte, Brazil|Cara Therapeutics Study Site, Joinville, 89227-680, Brazil|Cara Therapeutics Study Site, Salvador, Brazil|Cara Therapeutics Study Site, São Bernardo Do Campo, Brazil|Cara Therapeutics Study Site, São José Do Rio Preto, Brazil|Cara Therapeutics Study Site, São Paulo, 09090-790, Brazil|Cara Therapeutics Study Site 2, São Paulo, Brazil|Cara Therapeutics Study Site, São Paulo, Brazil|Cara Therapeutics Study Site, Dobrich, Bulgaria|Cara Therapeutics Study Site, Gabrovo, Bulgaria|Cara Therapeutics Study Site, Montana, Bulgaria|Cara Therapeutics Study Site, Plovdiv, Bulgaria|Cara Therapeutics Study Site, Heilbronn, Germany|Cara Therapeutics Study Site, Kaiserslautern, Germany|Cara Therapeutics Study Site, Baja, Hungary|Cara Therapeutics Study Site, Budapest, Hungary|Cara Therapeutics Study Site, Kistarcsa, Hungary|Cara Therapeutics Study Site, Pécs, Hungary|Cara Therapeutics Study Site, Firenze, Italy|Cara Therapeutics Study Site, Modena, 41124, Italy|Cara Therapeutics Study Site, Pavia, 27100, Italy|Cara Therapeutics Study Site, Roma, Italy|Cara Therapeutics Study Site, Daegu, Korea, Republic of|Cara Therapeutics Study Site 2, Goyang-si, Korea, Republic of|Cara Therapeutics Study Site, Goyang-si, Korea, Republic of|Cara Therapeutics Study Site, Seoul, 03080, Korea, Republic of|Cara Therapeutics Study Site, Seoul, Korea, Republic of|Cara Therapeutics Study Site, Aguas Calientes, Mexico|Cara Therapeutics Study Site, Durango, Mexico|Cara Therapeutics Study Site, Guadalajara, Mexico|Cara Therapeutics Study Site, Mérida, Mexico|Cara Therapeutics Study Site, Golub-Dobrzyń, Poland|Cara Therapeutics Study Site, Katowice, Poland|Cara Therapeutics Study Site 2, Kraków, Poland|Cara Therapeutics Study Site, Kraków, Poland|Cara Therapeutics Study Site, Szczecin, Poland|Cara Therapeutics Study Site, Wrocław, Poland|Cara Therapeutics Study Site, Łódź, Poland|Cara Therapeutics Study Site, Bucharest, Romania|Cara Therapeutics Study Site, Oradea, Romania|Cara Therapeutics Study Site, Timişoara, Romania|Cara Therapeutics Study Site, Almería, 04009, Spain|Cara Therapeutics Study Site, Badalona, Spain|Cara Therapeutics Study Site, Barcelona, Spain|Cara Therapeutics Study Site, Ferrol, 15405, Spain|Cara Therapeutics Study Site, Madrid, Spain|Cara Therapeutics Study Site, Palma De Mallorca, Spain|Cara Therapeutics Study Site 2, Valencia, Spain|Cara Therapeutics Study Site, Valencia, Spain|Cara Therapeutics Study Site, Vitoria, Spain
URL: https://clinicaltrials.gov/show/NCT05356403

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress