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Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus

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ClinicalTrials.gov Identifier: NCT02229929
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Cara Therapeutics, Inc.

Brief Summary:

The primary purpose of this study is to:

  • Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week in patients who are undergoing hemodialysis. (Part A)
  • This study is also investigating whether repeated doses of IV CR845 over two weeks is safe and effective in reducing the intensity of itching in hemodialysis patients with uremic pruritus (Part B).

Condition or disease Intervention/treatment Phase
Pruritus Uremic Pruritus Drug: Part A: Placebo Drug: Part A: CR845 0.5 mcg/kg Drug: Part A: CR845 1.0 mcg/kg Drug: Part A: CR845 2.5 mcg/kg Drug: Part B: Placebo Drug: Part B: CR845 1.0 mcg/kg Phase 2

Detailed Description:
Placebo-controlled

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Intravenous CR845 in Hemodialysis Patients, and Its Safety and Efficacy in Hemodialysis Patients With Uremic Pruritus
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Itching

Arm Intervention/treatment
Placebo Comparator: Part A: Placebo
Intravenous matched placebo
Drug: Part A: Placebo
Part A: Single i.v. dose of Placebo administered after each dialysis session over a 1 week treatment period (3 times per week)
Other Name: Matched Placebo

Experimental: Part A: CR845 0.5 mcg/kg
Intravenous CR845, 0.5 mcg/kg
Drug: Part A: CR845 0.5 mcg/kg
Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)
Other Name: CR845 0.5 mcg/kg

Experimental: Part A: CR845 1.0 mcg/kg
Intravenous CR845, 1.0 mcg/kg
Drug: Part A: CR845 1.0 mcg/kg
Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)
Other Name: CR845 1.0 mcg/kg

Experimental: Part A: CR845 2.5 mcg/kg
Intravenous CR845, 2.5 mcg/kg
Drug: Part A: CR845 2.5 mcg/kg
Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)
Other Name: CR845 2.5 mcg/kg

Placebo Comparator: Part B: Placebo
Intravenous matched placebo
Drug: Part B: Placebo
Part B: Single i.v. dose of Placebo administered after each dialysis session over a 2 week treatment period (3 times per week)
Other Name: Matched Placebo

Experimental: Part B: CR845 1.0 mcg/kg
Intravenous CR845, 1.0 mcg/kg
Drug: Part B: CR845 1.0 mcg/kg
Part B: Single i.v. dose of CR845 administered after each dialysis session over a 2 week treatment period (3 times per week)
Other Name: CR845 1.0 mcg/kg




Primary Outcome Measures :
  1. Part A: Determine the Pharmacokinetics of Repeated Doses of CR845 in Hemodialysis Patients (half-life, Cmax, Tmax, AUC, Vd) [ Time Frame: 1 week ]
    To evaluate the pharmacokinetics of repeated doses of CR845 in hemodialysis patients over a one-week treatment period.

  2. Part B: Change in Worst Itching Intensity using a 100-mm Visual Analog Scale [ Time Frame: 2 weeks ]
    Change from baseline to the average of Week 2 worst itching (daytime and nighttime) VAS where 0 mm represents "No Itch" and 100 mm represents the "Worst Itch You Can Imagine".


Secondary Outcome Measures :
  1. Part B: Change in quality-of-life assessed using the Skindex-10 survey [ Time Frame: 2 weeks ]
    Change from baseline to Day 15 in itch-related quality of life as assessed by the total Skindex-10 scores

  2. Part B: Sleep disturbance assessed using Itch Medical Outcomes Study (MOS) survey [ Time Frame: 2 weeks ]
    Change from baseline to Day 15 in itch-related sleep disturbance based on the Itch MOS sleep problems index II (SLP-9)



Information from the National Library of Medicine

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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:

  • Able to provide written informed consent prior to any study procedures;
  • Able to communicate clearly with the Investigator and staff, able to read and understand the study procedures;
  • Males or females 18 years of age or older;
  • End stage renal disease (ESRD) patients who have been on hemodialysis for at least three months and are currently on hemodialysis:

    • At least three times per week (Part A)
    • Three times per week (Part B)
  • Has a body weight ≤ 135 kg
  • Part B: Patient who self-reports daily or near daily pruritus during the 6 weeks prior to Screening;
  • Part B: Patient who reports a Patient B or Patient C profile on the Patient Self-categorization of Pruritus Disease Severity questionnaire at Screening;
  • Part B: At the end of the Run-in Period:

    • Patient who completed ratings of worst itching intensity [visual analog scale (VAS)] at least 8 times out of 14 VAS assessments;
    • Patient who has a mean value of >40 mm on the worst itching VAS over the one week Run-in Period.

Exclusion criteria:

  • Known to be non-compliant with dialysis treatment (i.e., has a history of missed dialysis sessions due to non-compliance in the past 2 months);
  • Anticipated to receive a kidney transplant during the study;
  • Known history of allergic reaction to opiates such as hives (Note: side effects related to the use of opioids such as constipation or nausea would not exclude the patients from the study);
  • Known or suspected history of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)-diagnosed alcohol, narcotic, or other drug abuse or dependence within 12 months prior to Screening;
  • Acute or unstable medical condition(s) such as congestive heart failure [New York Heart Association (NYHA) class IV], which in the opinion of the Investigator would pose undue risk to the patient or would impede complete collection of the data or its evaluability;
  • Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5X the reference upper limit of normal (ULN), or bilirubin greater than 4X the ULN at Screening;
  • Received another investigational drug within 30 days prior to the start of the Run-in Period or has planned to participate in another clinical trial while enrolled in this study
  • Part B: Has pruritus probably or definitely attributed to a cause other than ESRD or its complications (e.g., patients with concomitant pruritic dermatological disease or cholestatic liver disease would be excluded). (Note: Patients whose pruritus is attributed to ESRD complications such as hyperparathyroidism, hyperphosphatemia, anemia, or the dialysis procedure or prescription may be enrolled);
  • Part B: Has localized itch restricted to the palms of the hands as determined from the Brief Itch Inventory diagram, completed during the Screening Period;
  • Part B: Has pruritus only during the dialysis session (by patient report);
  • Part B: Has used gabapentin, calcineurin inhibitors, opioids; antipsychotics; systemic or topical corticosteroids (other than otic or ophthalmic preparations); sedatives; hypnotics; anti-anxiety agents selective serotonin reuptake inhibitors (SSRIs); or tricyclic antidepressants for < 4 weeks prior to the start of the Run-In Period or had a dose change within the previous 30 days;
  • Part B: Is not willing to abstain from use of antihistamines (oral, IV, or topical) for 3 weeks (from the start of the Run-In Period through the end of Week 2);
  • Part B: Not willing to abstain from making changes to topical non-drug treatments (e.g., emollients, creams, oils) for pruritus for 3 weeks (from the start of the Run-In Period through the end of Week 2);
  • Part B: Received ultraviolet B treatment within 30 days prior to the start of the Run-in Period.

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): NCT02229929


Locations
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United States, Arkansas
US Renal Care
Pine Bluff, Arkansas, United States, 71603
United States, California
US Renal Care
Chula Vista, California, United States, 91915
US Renal Care
Long Beach, California, United States, 90806
Valley Renal Medical Group
Northridge, California, United States, 91324
Nephrology Specialists Medical Group, Inc
Orange, California, United States, 92868
North American Research Institute
San Dimas, California, United States, 91773
United States, Florida
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, United States, 32209
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Emory Dialysis Center at Northside
Atlanta, Georgia, United States, 30318
United States, Massachusetts
Western New England Renal & Transplant Associates, PC
Springfield, Massachusetts, United States, 01107
United States, New Mexico
US Renal Care
Gallup, New Mexico, United States, 87301
United States, New York
Trude Weishaupt Memorial Dialysis Center
Fresh Meadows, New York, United States, 11365
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Brookview Hills Research Associates, LLC
Winston Salem, North Carolina, United States, 27103
United States, South Carolina
US Renal Care
Aiken, South Carolina, United States, 29803
United States, Tennessee
Southeast Renal Research Institute
Chattanooga, Tennessee, United States, 37408
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
US Renal Care
Grand Prairie, Texas, United States, 75050
US Renal Care
San Antonio, Texas, United States, 78202
Sponsors and Collaborators
Cara Therapeutics, Inc.
Investigators
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Study Director: Frederique Menzaghi, PhD Cara Therapeutics, Inc.

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Responsible Party: Cara Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02229929     History of Changes
Other Study ID Numbers: CR845-CLIN2005
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Keywords provided by Cara Therapeutics, Inc.:
Pruritus
uremic pruritus
kappa opioid
CR845
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms