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Trial record 4 of 29 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.

Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE May 6, 2019
Actual Primary Completion Date February 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • 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".
  • 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".
  • 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".
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Official Title  ICMJE An Open-Label, Multicenter Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uremic Pruritus
Intervention  ICMJE Drug: CR845 0.5 mcg/kg
IV CR845 0.5 mcg/kg administered three times/week
Other Names:
  • CR845
  • Difelikefalin
Study Arms  ICMJE Experimental: CR845 0.5mcg/kg
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Intervention: Drug: CR845 0.5 mcg/kg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2020)
222
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
400
Actual Study Completion Date  ICMJE March 6, 2020
Actual Primary Completion Date February 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Hungary,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998163
Other Study ID Numbers  ICMJE CR845-CLIN3105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cara Therapeutics, Inc.
Study Sponsor  ICMJE Cara Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Frédérique Menzaghi, PhD Cara Therapeutics
PRS Account Cara Therapeutics, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP