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Trial record 4 of 28 for:    Cara Therapeutics

CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis 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: NCT03998163
Recruitment Status : Completed
First Posted : June 26, 2019
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Cara Therapeutics, Inc.

Brief Summary:
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.

Condition or disease Intervention/treatment Phase
Uremic Pruritus Drug: CR845 0.5 mcg/kg Phase 3

Detailed Description:

Screening Period: The Screening Period includes a Screening Visit and a Run-In Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 21 days prior to the start of the Run-in Period. Patients will start the Run-in Period during the week prior to Treatment Period to complete eligibility verification.

Treatment Period: All scheduled study visits during the Treatment Period will be conducted on dialysis days. Patients will be administered CR845 as an IV bolus after the end of their dialysis during a Treatment Period of up to 12 weeks so that each patient will receive CR845 3 times weekly for a total of up to 36 doses. End of treatment (EOT) is defined as the first day of dialysis following the last dose of drug. The EOT procedures will be conducted on the dialysis visit following the last dose of study drug.

Follow-up Visit: A final safety Follow up Visit will be conducted 7-10 days after the EOT/Early Termination Visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Actual Study Start Date : May 6, 2019
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : March 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Itching

Arm Intervention/treatment
Experimental: CR845 0.5mcg/kg
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Drug: CR845 0.5 mcg/kg
IV CR845 0.5 mcg/kg administered three times/week
Other Names:
  • CR845
  • Difelikefalin




Primary Outcome Measures :
  1. The severity, seriousness and relationship of adverse events (including an abnormal laboratory finding) to CR845. [ Time Frame: Up to Follow-Up Visit (Week 13-14) ]
    Assessed by monitoring of adverse events.

  2. Safety as assessed by vital sign measurements: Body Temperature. [ Time Frame: Baseline, Up to Follow-Up Visit (Week 13-14) ]
    Changes in Body Temperature will be assessed.

  3. Safety as assessed by vital sign measurements: Heart Rate. [ Time Frame: Baseline, Up to Follow-Up Visit (Week 13-14) ]
    Changes in Heart Rate will be assessed.

  4. Safety as assessed by vital sign measurements: Blood Pressure. [ Time Frame: Baseline, Up to Follow-Up Visit (Week 13-14) ]
    Changes in Blood Pressure will be assessed.

  5. Safety as assessed by 12-lead ECG measurements. [ Time Frame: Baseline, Up to End of Treatment Visit (Week 13) ]
    Clinically significant abnormalities or worsening findings observed after the first dose of study drug will be reported as treatment-emergent adverse events.


Secondary Outcome Measures :
  1. Change from baseline in the weekly mean of the 24-hour Worst Itching Intensity NRS score each assessment of the Treatment Period (Week 4, 8, and Week 12). [ Time Frame: Baseline, Week 4, Week 8, 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".

  2. Proportion of patients achieving >0, ≥1, ≥2, ≥3, and ≥4-point improvement from baseline with respect to the weekly mean of the daily 24-hour Worst Itching Intensity NRS at Week 4, 8 and 12 of the Treatment Period. [ Time Frame: Baseline, Week 4, Week 8, 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".

  3. Change from baseline in the weekly mean of the 24-hour Sleep Quality score at each assessment of the Treatment Period (Week 4, 8, and Week 12). [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
    The impact of itch on patients' quality of sleep will be measured using an NRS used to indicate how the itch interferes with sleep over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "did not interfere" and "10" represents "completely interfered".

  4. Change from baseline in itch-related quality of life at each assessment of the Treatment Period (End of Week 4, 8, and 12) as assessed by the 5-D Itch and Skindex-10 Total score and each 5-D Itch individual questions or Skindex-10 subdomain score. [ Time Frame: Baseline, Week 4, Week 8, 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. 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.

  5. Patient health state and Proportion of patients with reported problems or no problems by level and EQ-5D-5L-P dimension will be summarized at baseline and each postbaseline time point (Week 4, 8, and Week 12). [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
    The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The EQ-PSO (Pruritis bolt-on) will be added to the EQ-5D-5L and includes two additional dimensions "skin irritation" and "self-confidence" to better capture the itch associated burdens.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

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

  • Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening;
  • Has at least 2 single-pool Kt/V measurements ≥1.2, or at least 2 urea reduction ratio measurements ≥65%, or 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis days during the 3 months period prior to screening;
  • Prior to Treatment:

    • Has completed at least 3 Worst Itching Intensity NRS questionnaires from the start of the Run-in Period up to and including the pre-dose assessment on Day 1;

Key Exclusion Criteria:

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

  • Known noncompliance with dialysis treatment that in the opinion of the investigator would impede completion or validity of the study;
  • Scheduled to receive a kidney transplant during the study;
  • New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening;
  • New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening;
  • Received another investigational drug within 30 days or five half-lives (whichever is longer) prior to the start of dosing or is planning to participate in another interventional clinical study while enrolled in this study;
  • Has pruritus only during the dialysis session (by patient report);
  • Is receiving ongoing ultraviolet B treatment and/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): NCT03998163


Locations
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United States, California
Cara Therapeutics Study Site
Escondido, California, United States, 92025
Cara Therapeutics Study Site
Riverside, California, United States, 92505
Cara Therapeutics Study Site
San Diego, California, United States, 92111
Cara Therapeutics Study Site
Victorville, California, United States, 92395
United States, Colorado
Cara Therapeutics Study Site
Denver, Colorado, United States, 80230
United States, Connecticut
Cara Therapeutics Study Site
Middlebury, Connecticut, United States, 06762
Cara Therapeutics Study Site
Norwich, Connecticut, United States, 06382
United States, Florida
Cara Therapeutics Study Site
Coral Gables, Florida, United States, 33134
Cara Therapeutics Study Site
Fort Lauderdale, Florida, United States, 33308
Cara Therapeutics Study Site
Hollywood, Florida, United States, 33024
Cara Therapeutics Study Site
Miami, Florida, United States, 33169
Cara Therapeutics Study Site 2
Tampa, Florida, United States, 33614
Cara Therapeutics Study Site
Tampa, Florida, United States, 33614
United States, Georgia
Cara Therapeutics Study Site
Albany, Georgia, United States, 31701
United States, Massachusetts
Cara Therapeutics Study Site
Boston, Massachusetts, United States, 02111
United States, Michigan
Cara Therapeutics Study Site
Roseville, Michigan, United States, 48066
United States, Minnesota
Cara Therapeutics Study Site
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Cara Therapeutics Study Site
Kansas City, Missouri, United States, 64131
United States, Nevada
Cara Therapeutics Study Site
Las Vegas, Nevada, United States, 89106
Cara Therapeutics Study Site 2
Las Vegas, Nevada, United States, 89128
United States, New York
Cara Therapeutics Study Site
Great Neck, New York, United States, 11021
United States, Pennsylvania
Cara Therapeutics Study Site
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Cara Therapeutics Study Site
Spartanburg, South Carolina, United States, 29302
United States, Tennessee
Cara Therapeutics Study Site
Knoxville, Tennessee, United States, 37920
United States, Texas
Cara Therapeutics Study Site
Austin, Texas, United States, 78751
Cara Therapeutics Study Site
Duncanville, Texas, United States, 75137
Cara Therapeutics Study Site
Greenville, Texas, United States, 75402
Cara Therapeutics Study Site
Mansfield, Texas, United States, 76063
Cara Therapeutics Study Site
Mesquite, Texas, United States, 75080
Cara Therapeutics Study Site 2
San Antonio, Texas, United States, 78221
Cara Therapeutics Study Site
San Antonio, Texas, United States, 78251
Cara Therapeutics Study Site 3
San Antonio, Texas, United States, 78258
Cara Therapeutics Study Site
Temple, Texas, United States, 76502
Czechia
Cara Therapeutics Study Site
Havlíčkův Brod, Czechia
Cara Therapeutics Study Site
Nové Město Na Moravě, Czechia
Cara Therapeutics Study Site
Praha, Czechia
Cara Therapeutics Study Site
Sokolov, Czechia
Hungary
Cara Therapeutics Study Site 2
Budapest, Hungary
Cara Therapeutics Study Site
Budapest, Hungary
Cara Therapeutics Study Site
Dunaújváros, Hungary
Cara Therapeutics Study Site
Kaposvár, Hungary
Cara Therapeutics Study Site
Kistarcsa, Hungary
Cara Therapeutics Study Site
Nyíregyháza, Hungary
Cara Therapeutics Study Site
Szombathely, Hungary
Poland
Cara Therapeutics Study Site
Ostrołęka, Poland
Cara Therapeutics Study Site
Radom, Poland
Cara Therapeutics Study Site
Sochaczew, Poland
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: NCT03998163    
Other Study ID Numbers: CR845-CLIN3105
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 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
Keywords provided by Cara Therapeutics, Inc.:
Hemodialysis
Pruritus
Uremic Pruritus
Dialysis
CR845
Chronic Itch
CKD
CKD-associated pruritus
CKD-aP
ESRD (end stage renal disease)
difelikefalin
Itch
Itching
KALM
Chronic Kidney Disease
Kidney failure, chronic
Kidney dysfunction
Generalized pruritus
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations