A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus



Status:Recruiting
Conditions:Allergy, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology, Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:July 5, 2018
End Date:December 2019
Contact:Michael Lue-Yat
Email:mlue-yat@caratherapeutics.com
Phone:203-406-3769

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A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the
safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the
intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus.
This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment
Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).

This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment
Period, and a Follow-up Visit (approximately 7 to 10 days after the last dose of study drug).
Informed consent will be obtained prior to performing any study-specific procedures.
Screening will occur within 7 to 28 days prior to randomization to assess eligibility.

If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day
Run-in Period, they will be randomized in a 1:1:1:1 ratio to receive orally once daily either
placebo or CR845 tablets at doses of 0.25, 0.5 or 1 mg. Randomization will be stratified
according to the patient's renal disease status: moderate CKD; severe CKD non-dialysis;
severe CKD on dialysis (ie, 3 categories). A final safety Follow-up Visit will be conducted 7
to 10 days after the last dose of study drug.

Inclusion Criteria:

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

- CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated
glomerular filtration rate (GFR) ≥30 and <60 mL/min/1.73 m2 or severe renal impairment
with estimated GFR <30 mL/min/1.73 m2).

- For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times
per week for at least 3 months prior to the start of screening;

- Prior to randomization:

1. Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of
the 7-day Run-in Period;

2. Has a mean baseline Worst Itching Intensity NRS score ≥5, defined as the average
of all non-missing scores reported from the start of the 7-day Run-in Period.

Exclusion Criteria:

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

- Patients not currently on dialysis who are likely to initiate routine dialysis during
study participation;

- Scheduled to receive a kidney transplant during the study;

- New or change of treatment received for itch including antihistamines and
corticosteroids (oral, intravenous [IV], or topical) within 14 days prior to
screening;

- Received another investigational drug within 30 days prior to the start of screening
or is planning to participate in another clinical study while enrolled in this study;

- Received ultraviolet B treatment within 30 days prior to the start of screening or
anticipates receiving such treatment during the study;

- Participated in a previous clinical study with CR845.
We found this trial at
51
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Peoria, Arizona 85351
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Alexandria, Virginia 22304
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Augusta, Georgia 30909
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Bakersfield, California 93309
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Bakersfield, California 99309
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Brooklyn, New York 11229
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Camp Hill, Pennsylvania 17011
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Canyon Country, California 91351
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Columbus, OH
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Corsicana, Texas 75110
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Crystal Lake, Illinois 60012
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Denver, Colorado 80218
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Edgewater, Florida 32132
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Escondido, California 92025
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Evanston, Illinois 60201
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Flint, Michigan 48504
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Flint, Michigan 48532
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Florence, Alabama 35630
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Gonzales, Texas 78629
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Greenville, South Carolina 29601
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Harrisburg, Arkansas 72432
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Hialeah, Florida 33016
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Hollywood, Florida 33024
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Houston, TX
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Kansas City, Missouri 64111
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Lake Worth, Florida 33462
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Lomita, California 90717
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Metairie, Louisiana 70006
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Miami, Florida 33125
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Mineola, New York 11501
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New Orleans, Louisiana 70112
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Norman, Oklahoma 73071
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Ocala, Florida 34471
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Orlando, Florida 32806
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Pembroke Pines, Florida 33028
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Phoenix, Arizona 85023
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Plano, Texas 75024
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Prescott, Arizona 86401
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Rapid City, South Dakota 57702
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Riverside, California 92505
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Rocky Mount, North Carolina 27804
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Roseville, Michigan 48066
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Sacramento, California 95831
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Saint Clair, Michigan 48081
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San Antonio, Texas 78221
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Sandy Springs, Georgia 30328
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Takoma Park, Maryland 20912
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Tampa, Florida 33634
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Washington, District of Columbia 20037
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Whittier, California 90603
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Zachary, Louisiana 70791
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