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

Primary Purpose

Chronic Kidney Diseases, Pruritus

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Difelikefalin 1 mg Oral Tablet
Placebo Oral Tablet
Sponsored by
Cara Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring 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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

  • Advanced stage 4 and 5 CKD not currently on dialysis
  • Subject self-reports experiencing daily or near-daily pruritus for at least 6 months prior to screening.
  • Inadequate response to current or prior topical treatments (including emollients) for pruritus prior to screening.

Prior to randomization on Day 1 of Treatment Period 1:

  1. Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and
  2. 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 screening.

Sites / Locations

  • Cara Therapeutics Study SiteRecruiting
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  • Cara Therapeutics Study Site 2Recruiting
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Difelikefalin 1 mg Oral Tablet

Placebo Oral Tablet

Arm Description

Patients receive oral difelikefalin 1 mg once daily

Patients receive oral placebo once daily

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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".
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".
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".
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".

Full Information

First Posted
April 18, 2022
Last Updated
October 5, 2023
Sponsor
Cara Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05342623
Brief Title
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cara Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in advanced chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study is comprised of an Efficacy Assessment Phase and a Long-term Extension Phase. The Efficacy Assessment Phase includes a double-blind 12-week Treatment Period (Treatment Period 1), and the Long-term Extension Phase includes a double-blind Treatment Period (Treatment Period 2) of up to 52 weeks.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Pruritus
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo controlled study
Masking
ParticipantInvestigator
Masking Description
Difelikefalin and placebo will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance. Difelikefalin tablets will be provided at doses of 1 mg.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Difelikefalin 1 mg Oral Tablet
Arm Type
Experimental
Arm Description
Patients receive oral difelikefalin 1 mg once daily
Arm Title
Placebo Oral Tablet
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo once daily
Intervention Type
Drug
Intervention Name(s)
Difelikefalin 1 mg Oral Tablet
Other Intervention Name(s)
CR845
Intervention Description
Difelikefalin 1 mg medication taken orally 1 time/day
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo tablet taken orally 1 time/day
Primary Outcome Measure Information:
Title
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
Description
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".
Time Frame
Week 12 of Treatment Period 1
Secondary Outcome Measure Information:
Title
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.
Description
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".
Time Frame
Week 8 of Treatment Period 1
Title
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.
Description
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".
Time Frame
Week 4 of Treatment Period 1
Title
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.
Description
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".
Time Frame
Week 12 of Treatment Period 1
Title
Efficacy Assessment Phase (Treatment Period 1): Change from baseline in Sleep Quality Questionnaire score at the end of Week 12 of Treatment Period 1.
Description
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".
Time Frame
Week 12 of Treatment Period 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cara Therapeutics
Phone
203-406-3700
Email
clinicaltrials.gov@caratherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédérique Menzaghi, PhD
Organizational Affiliation
Cara Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Cara Therapeutics Study Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
S. Gate
State/Province
California
ZIP/Postal Code
90280
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Santa Clara
State/Province
California
ZIP/Postal Code
91351
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Victorville
State/Province
California
ZIP/Postal Code
92392
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33914
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site 2
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Riverview
State/Province
Florida
ZIP/Postal Code
33578
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
East Point
State/Province
Georgia
ZIP/Postal Code
30344
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Huntley
State/Province
Illinois
ZIP/Postal Code
60142
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
48504
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Saint Clair
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Laurelton
State/Province
New York
ZIP/Postal Code
11413
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18107
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29302
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37924
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Sites
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Greenville
State/Province
Texas
ZIP/Postal Code
75402
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site 2
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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