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Trial record 6 of 29 for:    Cara Therapeutics

A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617536
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Cara Therapeutics, Inc.

Brief Summary:
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Pruritus Drug: CR845 0.25 mg Oral Tablet Drug: CR845 0.5 mg Oral Tablet Drug: CR845 1 mg Oral Tablet Drug: Placebo Oral Tablet Phase 2

Detailed Description:

This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 to 10 days after the last dose of study drug). 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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo controlled study
Masking: Double (Participant, Investigator)
Masking Description:

CR845 will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose.

CR845 tablets will be provided at doses of 0.25, 0.5, and 1 mg.

Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Actual Study Start Date : July 5, 2018
Actual Primary Completion Date : October 24, 2019
Actual Study Completion Date : November 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CR845 0.25 mg Oral Tablet
Oral CR845 0.25 mg to be taken orally once daily for 12 weeks
Drug: CR845 0.25 mg Oral Tablet
CR845 0.25 mg medication taken orally 1 time/day
Other Name: Difelikefalin

Experimental: CR845 0.5 mg Oral Tablet
Oral CR845 0.5 mg to be taken orally once daily for 12 weeks
Drug: CR845 0.5 mg Oral Tablet
CR845 0.5 mg medication taken orally 1 time/day
Other Name: Difelikefalin

Experimental: CR845 1 mg Oral Tablet
Oral CR845 1 mg to be taken orally once daily for 12 weeks
Drug: CR845 1 mg Oral Tablet
CR845 1 mg medication taken orally 1 time/day
Other Name: Difelikefalin

Placebo Comparator: Placebo Oral Tablet
Oral Placebo to be taken orally once daily
Drug: Placebo Oral Tablet
Placebo tablet taken orally 1 time/day




Primary Outcome Measures :
  1. Reduction of itch-intensity as assessed by the change from baseline in weekly mean of the daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) score during Week 12 [ Time Frame: Baseline, Week 12 ]
    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".


Secondary Outcome Measures :
  1. Improvement in itch-related quality of life as assessed by the change from baseline in total Skindex-10 Scale score at the end of Week 12 [ Time Frame: Baseline, Week 12 ]
    The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. A lower total score represents better quality of life.

  2. Improvement in itch-related quality of life as assessed by the change from baseline in 5-D Itch Scale score at the end of Week 12 [ Time Frame: Baseline, Week 12 ]
    The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. A lower total score represents better quality of life.

  3. Reduction of itch intensity as assessed by the proportion of patients achieving an improvement from baseline ≥3 points with respect to the weekly mean of the daily 24-hour Worst Itching Intensity NRS score at Week 12 [ Time Frame: Week 12 ]
    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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following 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:

A patient will be excluded from the study if any of the following criteria are met:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617536


Locations
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United States, Alabama
Cara Therapeutics Study Site
Birmingham, Alabama, United States, 35233
Cara Therapeutics Study Site
Florence, Alabama, United States, 35630
United States, Arizona
Cara Therapeutics Study Site
Phoenix, Arizona, United States, 85016
Cara Therapeutics Study Site
Prescott, Arizona, United States, 86401
Cara Therapeutics Study Site
Sun City, Arizona, United States, 85351
United States, Arkansas
Cara Therapeutics Study Site
Harrisburg, Arkansas, United States, 72432
United States, California
Cara Therapeutics Study Site
Bakersfield, California, United States, 93309
Cara Therapeutics Study Site 2
Bakersfield, California, United States, 99309
Cara Therapeutics Study Site
Canyon Country, California, United States, 91351
Cara Therapeutics Study Site
Escondido, California, United States, 92025
Cara Therapeutics Study Site
Lomita, California, United States, 90717
Cara Therapeutics Study Site
Northridge, California, United States, 91324
Cara Therapeutics Study Site
Riverside, California, United States, 92505
Cara Therapeutics Study Site
Sacramento, California, United States, 95831
Cara Therapeutics Study Site
Whittier, California, United States, 90602
United States, Colorado
Cara Therapeutics Study Site
Denver, Colorado, United States, 80230
United States, District of Columbia
Cara Therapeutics Study Site
Washington, District of Columbia, United States, 20037
United States, Florida
Cara Therapeutics Study Site
Edgewater, Florida, United States, 32132
Cara Therapeutics Study Site
Hialeah, Florida, United States, 33016
Cara Therapeutics Study Site
Hollywood, Florida, United States, 33024
Cara Therapeutics Study Site
Lake Worth, Florida, United States, 33467
Cara Therapeutics Study Site 1
Miami, Florida, United States, 33125
Cara Therapeutics Study Site 2
Miami, Florida, United States, 33155
Cara Therapeutics Study Site
Ocala, Florida, United States, 34471
Cara Therapeutics Study Site
Orlando, Florida, United States, 32810
Cara Therapeutics Study Site
Tampa, Florida, United States, 33614
Cara Therapeutics Study Site
Temple Terrace, Florida, United States, 33637
United States, Georgia
Cara Therapeutics Study Site
Augusta, Georgia, United States, 30909
Cara Therapeutics Study Site
Sandy Springs, Georgia, United States, 30328
United States, Illinois
Cara Therapeutics Study Site
Crystal Lake, Illinois, United States, 60012
Cara Therapeutics Study Site
Evanston, Illinois, United States, 60201
United States, Iowa
Cara Therapeutics Study Site
Iowa City, Iowa, United States, 52242
United States, Louisiana
Cara Therapeutics Study Site
Metairie, Louisiana, United States, 70006
Cara Therapeutics Study Site
New Orleans, Louisiana, United States, 70115
Cara Therapeutics Study Site
Zachary, Louisiana, United States, 70791
United States, Maryland
Cara Therapeutics Study Site
Baltimore, Maryland, United States, 21287
Cara Therapeutics Study Site
Takoma Park, Maryland, United States, 20912
United States, Michigan
Cara Therapeutics Study Site
Flint, Michigan, United States, 48503
Cara Therapeutics Study Site 2
Flint, Michigan, United States, 48532
Cara Therapeutics Study Site
Roseville, Michigan, United States, 48066
Cara Therapeutics Study Site
Saint Clair, Michigan, United States, 48081
United States, Missouri
Cara Therapeutics Study Site
Kansas City, Missouri, United States, 64111
United States, New York
Cara Therapeutics Study Site
Brooklyn, New York, United States, 11229
Cara Therapeutics Study Site
Mineola, New York, United States, 11501
United States, North Carolina
Cara Therapeutics Study Site
Rocky Mount, North Carolina, United States, 27804
United States, Ohio
Cara Therapeutics Study Site
Columbus, Ohio, United States, 43215
United States, Oklahoma
Cara Therapeutics Study Site
Norman, Oklahoma, United States, 73071
United States, Pennsylvania
Cara Therapeutics Study Site
Camp Hill, Pennsylvania, United States, 17011
United States, Rhode Island
Cara Therapeutics Study Site
Providence, Rhode Island, United States, 02903
Cara Therapeutics Study Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Cara Therapeutics Study Site
Greenville, South Carolina, United States, 29605
United States, South Dakota
Cara Therapeutics Study Site
Rapid City, South Dakota, United States, 57702
United States, Texas
Cara Therapeutics Study Site
Corsicana, Texas, United States, 75110
Cara Therapeutics Study Site
Gonzales, Texas, United States, 78629
Cara Therapeutics Study Site
Houston, Texas, United States, 77074
Cara Therapeutics Study Site
Houston, Texas, United States, 77081
Cara Therapeutics Study Site
Plano, Texas, United States, 75093
Cara Therapeutics Study Site
San Antonio, Texas, United States, 78207
Cara Therapeutics Study Site
San Antonio, Texas, United States, 78224
United States, Virginia
Cara Therapeutics Study Site
Alexandria, Virginia, United States, 22304
Sponsors and Collaborators
Cara Therapeutics, Inc.
Investigators
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Study Director: Frédérique Menzaghi, PhD Cara Therapeutics
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Responsible Party: Cara Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03617536    
Other Study ID Numbers: CR845 210301
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cara Therapeutics, Inc.:
difelikefalin
CR845
Pruritus
Chronic Itch
Itch
Itching
uremic pruritus
CKD
CKD-aP
CKD-associated pruritus
Chronic Kidney Disease
Kidney dysfunction
Generalized pruritus
Hemodialysis
Dialysis
ESRD (end stage renal disease)
Kidney failure, chronic
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Pruritus
Urologic Diseases
Renal Insufficiency
Skin Diseases
Skin Manifestations