- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05356403
CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
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
Study Overview
Status
Conditions
Intervention / Treatment
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 (EOT)/Early 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 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Cara Therapeutics
- Phone Number: 203-406-3700
- Email: clinicaltrials.gov@caratherapeutics.com
Study Locations
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Ciudad Autonoma de Buenos Aire, Argentina, C1425DES
- Recruiting
- Cara Therapeutics Study Site
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Corrientes, Argentina, W3400AMZ
- Recruiting
- Cara Therapeutics Study Site
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Lanús, Argentina, B1824KAJ
- Recruiting
- Cara Therapeutics Study Site
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Mar Del Plata, Argentina
- Recruiting
- Cara Therapeutics Study Site
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San Nicolás, Argentina, 2900
- Recruiting
- Cara Therapeutics Study Site
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Sarandí, Argentina, 1872
- Recruiting
- Cara Therapeutics Study Site
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Adelaide, Australia
- Recruiting
- Cara Therapeutics Study Site
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Camperdown, Australia
- Recruiting
- Cara Therapeutics Study Site
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Concord, Australia
- Recruiting
- Cara Therapeutics Study Site
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Gosford, Australia
- Recruiting
- Cara Therapeutics Study Site
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Kogarah, Australia
- Recruiting
- Cara Therapeutics Study Site
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Launceston, Australia
- Recruiting
- Cara Therapeutics Study Site
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Liverpool, Australia
- Recruiting
- Cara Therapeutics Study Site
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Melbourne, Australia
- Recruiting
- Cara Therapeutics Study Site
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Saint Albans, Australia
- Recruiting
- Cara Therapeutics Study Site
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Westmead, Australia
- Recruiting
- Cara Therapeutics Study Site
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Belo Horizonte, Brazil
- Recruiting
- Cara Therapeutics Study Site
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Joinville, Brazil, 89227-680
- Recruiting
- Cara Therapeutics Study Site
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Salvador, Brazil
- Recruiting
- Cara Therapeutics Study Site
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São Bernardo Do Campo, Brazil
- Recruiting
- Cara Therapeutics Study Site
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São José Do Rio Preto, Brazil
- Recruiting
- Cara Therapeutics Study Site
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São Paulo, Brazil, 09090-790
- Recruiting
- Cara Therapeutics Study Site
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São Paulo, Brazil
- Recruiting
- Cara Therapeutics Study Site 2
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São Paulo, Brazil
- Recruiting
- Cara Therapeutics Study Site
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Dobrich, Bulgaria
- Recruiting
- Cara Therapeutics Study Site
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Gabrovo, Bulgaria
- Recruiting
- Cara Therapeutics Study Site
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Montana, Bulgaria
- Recruiting
- Cara Therapeutics Study Site
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Plovdiv, Bulgaria
- Recruiting
- Cara Therapeutics Study Site
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Stara Zagora, Bulgaria
- Recruiting
- Cara Therapeutics Study Sites
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Heilbronn, Germany
- Recruiting
- Cara Therapeutics Study Site
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Kaiserslautern, Germany
- Recruiting
- Cara Therapeutics Study Site
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Baja, Hungary
- Recruiting
- Cara Therapeutics Study Site
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Budapest, Hungary
- Recruiting
- Cara Therapeutics Study Site
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Kistarcsa, Hungary
- Recruiting
- Cara Therapeutics Study Site
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Pécs, Hungary
- Recruiting
- Cara Therapeutics Study Site
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Firenze, Italy
- Recruiting
- Cara Therapeutics Study Site
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Modena, Italy, 41124
- Recruiting
- Cara Therapeutics Study Site
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Pavia, Italy, 27100
- Recruiting
- Cara Therapeutics Study Site
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Roma, Italy
- Recruiting
- Cara Therapeutics Study Site
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Daegu, Korea, Republic of
- Recruiting
- Cara Therapeutics Study Site
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Goyang-si, Korea, Republic of
- Recruiting
- Cara Therapeutics Study Site
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Goyang-si, Korea, Republic of
- Recruiting
- Cara Therapeutics Study Site 2
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Seoul, Korea, Republic of
- Recruiting
- Cara Therapeutics Study Site
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Seoul, Korea, Republic of, 03080
- Recruiting
- Cara Therapeutics Study Site
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Aguas Calientes, Mexico
- Recruiting
- Cara Therapeutics Study Site
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Durango, Mexico
- Recruiting
- Cara Therapeutics Study Site
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Guadalajara, Mexico
- Recruiting
- Cara Therapeutics Study Site
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Mérida, Mexico
- Recruiting
- Cara Therapeutics Study Site
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Golub-Dobrzyń, Poland
- Recruiting
- Cara Therapeutics Study Site
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Katowice, Poland
- Recruiting
- Cara Therapeutics Study Site
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Kraków, Poland
- Recruiting
- Cara Therapeutics Study Site 2
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Kraków, Poland
- Recruiting
- Cara Therapeutics Study Site
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Szczecin, Poland
- Recruiting
- Cara Therapeutics Study Site
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Wrocław, Poland
- Recruiting
- Cara Therapeutics Study Site
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Łódź, Poland
- Recruiting
- Cara Therapeutics Study Site
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Bucharest, Romania
- Recruiting
- Cara Therapeutics Study Site
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Deva, Romania
- Recruiting
- Cara Therapeutics Study Site
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Oradea, Romania
- Recruiting
- Cara Therapeutics Study Site
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Timişoara, Romania
- Recruiting
- Cara Therapeutics Study Site
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Almería, Spain, 04009
- Recruiting
- Cara Therapeutics Study Site
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Badalona, Spain
- Recruiting
- Cara Therapeutics Study Site
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Barcelona, Spain
- Recruiting
- Cara Therapeutics Study Site
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Ferrol, Spain, 15405
- Recruiting
- Cara Therapeutics Study Site
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Madrid, Spain
- Recruiting
- Cara Therapeutics Study Site
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Palma De Mallorca, Spain
- Recruiting
- Cara Therapeutics Study Site
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Valencia, Spain
- Recruiting
- Cara Therapeutics Study Site
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Valencia, Spain
- Recruiting
- Cara Therapeutics Study Site 2
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Vitoria, Spain
- Recruiting
- Cara Therapeutics Study Site
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California
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Northridge, California, United States, 91324
- Recruiting
- Cara Therapeutics Study Site
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Florida
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Miami, Florida, United States, 33032
- Recruiting
- Cara Therapeutics Study Site
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Miami Lakes, Florida, United States, 33014
- Recruiting
- Cara Therapeutics Study Site
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Miami Lakes, Florida, United States, 33016
- Recruiting
- Cara Therapeutics Study Site
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Weston, Florida, United States, 33331
- Recruiting
- Cara Therapeutics Study Site
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Georgia
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Brunswick, Georgia, United States, 31520
- Recruiting
- Cara Therapeutics Study Site
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New York
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New York, New York, United States, 10016
- Recruiting
- Cara Therapeutics Study Site
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South Carolina
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Orangeburg, South Carolina, United States, 29118
- Recruiting
- Cara Therapeutics Study Site
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Texas
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Sugar Land, Texas, United States, 77476
- Recruiting
- Cara Therapeutics Study Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
To be eligible for inclusion into the study, a patient must meet the following 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:
- Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and
- 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:
A patient will be excluded from the study if any of the following criteria are met:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Difelikefalin 1 mg Oral Tablet
Patients receive oral difelikefalin 1 mg once daily
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Difelikefalin 1 mg medication taken orally 1 time/day
Other Names:
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Placebo Comparator: Placebo Oral Tablet
Patients receive oral placebo once daily
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Placebo tablet taken orally 1 time/day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
Time Frame: Week 12 of Treatment Period 1
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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".
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Week 12 of Treatment Period 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Week 8 of Treatment Period 1
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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".
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Week 8 of Treatment Period 1
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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.
Time Frame: Week 4 of Treatment Period 1
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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".
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Week 4 of Treatment Period 1
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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.
Time Frame: Week 12 of Treatment Period 1
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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".
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Week 12 of Treatment Period 1
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Efficacy Assessment Phase (Treatment Period 1): Change from baseline in Sleep Quality Questionnaire score at the end of Week 12 of Treatment Period 1.
Time Frame: Week 12 of Treatment Period 1
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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".
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Week 12 of Treatment Period 1
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Frédérique Menzaghi, PhD, Cara Therapeutics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Skin Manifestations
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Pruritus
Other Study ID Numbers
- CR845-310302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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