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Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

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ClinicalTrials.gov Identifier: NCT03281538
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Cara Therapeutics, Inc.

Brief Summary:
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.

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

Detailed Description:

This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks. This study will consist of a Screening Visit, a 52 week Treatment Period, and a Follow-up Visit. Informed consent will be obtained prior to performing any study-specific procedures. All patients will have a Screening Visit, which can be performed anytime within 14 days prior to the first dose of study drug, to confirm eligibility.

Clinical laboratory tests, electrocardiograms (ECGs), vital signs, adverse events, and concomitant medications will be monitored throughout the study. Blood samples for inflammatory biomarkers will be collected from all patients prior to dialysis on Day 1 and periodically until the End of Treatment or Early Termination Visit. Blood samples will also be collected periodically for clinical laboratory tests.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Extension Study to Evaluate the Long Term Safety of Intravenous CR845 in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

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




Primary Outcome Measures :
  1. Safety of IV CR845 based on physical examination; adverse events, vital signs and changes in laboratory tests. [ Time Frame: Up to 52 weeks ]
    Assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments



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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:

  1. Willing and able to provide written informed consent prior to participating in this study;
  2. Able to communicate clearly with the Investigator and staff, able to understand the study procedures, and able and willing to comply with the study schedules and all study requirements;
  3. Males or females 18 years of age or older;
  4. Currently on hemodialysis for end-stage renal disease and has been categorized as experiencing moderate to severe uremic pruritus;
  5. If female:

    1. Is not of childbearing potential (surgically sterile or postmenopausal, as defined in Section 6.5.1.6); or
    2. Has a negative serum pregnancy test at screening and agrees to use acceptable contraceptive measures (as defined in Section 6.5.1.6) from the time of informed consent until the safety Follow-up Visit or 7 days after the last dose of study drug, whichever is later.
  6. If male, agrees not to donate sperm after the first dose of study drug until 7 days after the last dose, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after study drug administration. (Note: No restrictions are required for a vasectomized male provided his vasectomy was performed ≥4 months prior to dosing);
  7. Has a dry body weight of ≥40.0 kg at screening (prescription target dry body weight);
  8. Has adequacy of dialysis, defined as meeting 1 of the following criteria during the 3 months prior to screening:

    1. ≥2 single pool Kt/V measurements ≥1.2; or
    2. ≥2 urea reduction ratio measurements ≥65%; or
    3. 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65%

Exclusion Criteria:

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

  1. Received an investigational drugwithin 30 days prior to the first dose of study drug, or is planning to participate in another interventional clinical study while enrolled in this study.
  2. Has a concomitant disease or any medical condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements, including, but not limited to:

    1. Known or suspected history of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, -diagnosed alcohol, narcotic or other drug abuse, or substance dependence within 12 months prior to screening;
    2. New York Heart Association Class IV congestive heart failure (Appendix 1, Section 14.0);
    3. Severe mental illness or cognitive impairment (eg, dementia);
    4. Any other relevant acute or chronic medical or neuropsychiatric condition;

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): NCT03281538


Contacts
Contact: Adam Russell 203-406-3754 arussell@caratherapeutics.com
Contact: Warren Wen 203-406-3700 wwen@caratherapeutics.com

  Show 31 Study Locations
Sponsors and Collaborators
Cara Therapeutics, Inc.
Investigators
Study Director: Frederique Menzaghi Cara Therapeutics

Responsible Party: Cara Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03281538     History of Changes
Other Study ID Numbers: CR845-CLIN3101
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms