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Trial record 1 of 1 for:    CR845-CLIN3105
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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
Results First Posted : October 15, 2021
Last Update Posted : October 15, 2021
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. Number of Participants With AEs. [ Time Frame: Up to Follow-Up Visit (Week 13-14) ]
    Assessed by monitoring of adverse events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Show Show 47 study locations
Sponsors and Collaborators
Cara Therapeutics, Inc.
Investigators
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Study Director: Frédérique Menzaghi, PhD Cara Therapeutics
  Study Documents (Full-Text)

Documents provided by Cara Therapeutics, Inc.:
Study Protocol  [PDF] February 12, 2019
Statistical Analysis Plan  [PDF] March 9, 2020

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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
Results First Posted: October 15, 2021
Last Update Posted: October 15, 2021
Last Verified: September 2021
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