A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
NCT ID: NCT03617536
Last Updated: 2024-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
269 participants
INTERVENTIONAL
2018-07-05
2019-11-14
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 1:1:1:1 ratio to receive orally once daily either placebo or CR845 tablets at doses of 0.25, 0.5 or 1 mg. Randomization will be stratified according to the patient's renal disease status: moderate CKD; severe CKD non-dialysis; severe CKD on dialysis (ie, 3 categories). A final safety Follow-up Visit will be conducted 7 to 10 days after the last dose of study drug.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
CR845 tablets will be provided at doses of 0.25, 0.5, and 1 mg.
Study Groups
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CR845 0.25 mg Oral Tablet
Oral CR845 0.25 mg to be taken orally once daily for 12 weeks
CR845 0.25 mg Oral Tablet
CR845 0.25 mg medication taken orally 1 time/day
CR845 0.5 mg Oral Tablet
Oral CR845 0.5 mg to be taken orally once daily for 12 weeks
CR845 0.5 mg Oral Tablet
CR845 0.5 mg medication taken orally 1 time/day
CR845 1 mg Oral Tablet
Oral CR845 1 mg to be taken orally once daily for 12 weeks
CR845 1 mg Oral Tablet
CR845 1 mg medication taken orally 1 time/day
Placebo Oral Tablet
Oral Placebo to be taken orally once daily
Placebo Oral Tablet
Placebo tablet taken orally 1 time/day
Interventions
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CR845 0.25 mg Oral Tablet
CR845 0.25 mg medication taken orally 1 time/day
CR845 0.5 mg Oral Tablet
CR845 0.5 mg medication taken orally 1 time/day
CR845 1 mg Oral Tablet
CR845 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
* CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated glomerular filtration rate (GFR) ≥30 and \<60 mL/min/1.73 m2 or severe renal impairment with estimated GFR \<30 mL/min/1.73 m2).
* For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening;
* Prior to randomization:
1. Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period;
2. Has a mean baseline Worst Itching Intensity NRS score ≥5, defined as the average of all non-missing scores reported from the start of the 7-day Run-in Period.
Exclusion Criteria
* Patients not currently on dialysis who are likely to initiate routine dialysis during study participation;
* Scheduled to receive a kidney transplant during the study;
* New or change of treatment received for itch including antihistamines and corticosteroids (oral, intravenous \[IV\], or topical) within 14 days prior to screening;
* Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study;
* Received ultraviolet B treatment within 30 days prior to the start of screening or anticipates receiving such treatment during the study;
* Participated in a previous clinical study with CR845.
18 Years
ALL
No
Sponsors
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Cara Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frédérique Menzaghi, PhD
Role: STUDY_DIRECTOR
Cara Therapeutics
Locations
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Cara Therapeutics Study Site
Birmingham, Alabama, United States
Cara Therapeutics Study Site
Florence, Alabama, United States
Cara Therapeutics Study Site
Phoenix, Arizona, United States
Cara Therapeutics Study Site
Prescott, Arizona, United States
Cara Therapeutics Study Site
Sun City, Arizona, United States
Cara Therapeutics Study Site
Harrisburg, Arkansas, United States
Cara Therapeutics Study Site
Bakersfield, California, United States
Cara Therapeutics Study Site 2
Bakersfield, California, United States
Cara Therapeutics Study Site
Canyon Country, California, United States
Cara Therapeutics Study Site
Escondido, California, United States
Cara Therapeutics Study Site
Lomita, California, United States
Cara Therapeutics Study Site
Northridge, California, United States
Cara Therapeutics Study Site
Riverside, California, United States
Cara Therapeutics Study Site
Sacramento, California, United States
Cara Therapeutics Study Site
Whittier, California, United States
Cara Therapeutics Study Site
Denver, Colorado, United States
Cara Therapeutics Study Site
Washington D.C., District of Columbia, United States
Cara Therapeutics Study Site
Edgewater, Florida, United States
Cara Therapeutics Study Site
Hialeah, Florida, United States
Cara Therapeutics Study Site
Hollywood, Florida, United States
Cara Therapeutics Study Site
Lake Worth, Florida, United States
Cara Therapeutics Study Site 1
Miami, Florida, United States
Cara Therapeutics Study Site 2
Miami, Florida, United States
Cara Therapeutics Study Site
Ocala, Florida, United States
Cara Therapeutics Study Site
Orlando, Florida, United States
Cara Therapeutics Study Site
Tampa, Florida, United States
Cara Therapeutics Study Site
Temple Terrace, Florida, United States
Cara Therapeutics Study Site
Augusta, Georgia, United States
Cara Therapeutics Study Site
Sandy Springs, Georgia, United States
Cara Therapeutics Study Site
Crystal Lake, Illinois, United States
Cara Therapeutics Study Site
Evanston, Illinois, United States
Cara Therapeutics Study Site
Iowa City, Iowa, United States
Cara Therapeutics Study Site
Metairie, Louisiana, United States
Cara Therapeutics Study Site
New Orleans, Louisiana, United States
Cara Therapeutics Study Site
Zachary, Louisiana, United States
Cara Therapeutics Study Site
Baltimore, Maryland, United States
Cara Therapeutics Study Site
Takoma Park, Maryland, United States
Cara Therapeutics Study Site
Flint, Michigan, United States
Cara Therapeutics Study Site 2
Flint, Michigan, United States
Cara Therapeutics Study Site
Roseville, Michigan, United States
Cara Therapeutics Study Site
Saint Clair, Michigan, United States
Cara Therapeutics Study Site
Kansas City, Missouri, United States
Cara Therapeutics Study Site
Brooklyn, New York, United States
Cara Therapeutics Study Site
Mineola, New York, United States
Cara Therapeutics Study Site
Rocky Mount, North Carolina, United States
Cara Therapeutics Study Site
Columbus, Ohio, United States
Cara Therapeutics Study Site
Norman, Oklahoma, United States
Cara Therapeutics Study Site
Camp Hill, Pennsylvania, United States
Cara Therapeutics Study Site
Providence, Rhode Island, United States
Cara Therapeutics Study Site
Warwick, Rhode Island, United States
Cara Therapeutics Study Site
Greenville, South Carolina, United States
Cara Therapeutics Study Site
Rapid City, South Dakota, United States
Cara Therapeutics Study Site
Corsicana, Texas, United States
Cara Therapeutics Study Site
Gonzales, Texas, United States
Cara Therapeutics Study Site
Houston, Texas, United States
Cara Therapeutics Study Site
Houston, Texas, United States
Cara Therapeutics Study Site
Plano, Texas, United States
Cara Therapeutics Study Site
San Antonio, Texas, United States
Cara Therapeutics Study Site
San Antonio, Texas, United States
Cara Therapeutics Study Site
Alexandria, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CR845 210301
Identifier Type: -
Identifier Source: org_study_id
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