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



Status:Active, not recruiting
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:February 20, 2018
End Date:March 2020

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A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the
safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each
dialysis session. The study includes a 12-week Double-blind Phase and a 52-week Open-label
Extension Phase.

Double-blind Phase The Double-blind Phase of the study will consist of a Screening Visit, a
7-day Run-in Period, a 12 week Double-blind Treatment Period, and a 2-week Discontinuation
Period. Informed consent will be obtained prior to performing any study-specific procedures.
The Screening Visit will occur within 7 to 28 days prior to randomization to assess
eligibility.

Open-label Extension Phase Patients who received at least 30 doses of study drug (either
active or placebo) during the 12-week Double-blind Treatment Period and continue to meet
other eligibility criteria will have the option to receive open label CR845 for an additional
52 weeks. The Open-label Extension Phase will be comprised of the Open-label Treatment Period
and the Follow-up Period.

The last dose of open-label study drug will be administered at the last dialysis visit on
Week 52, or Early Termination. A final safety Follow up Visit will be conducted 7-10 days
after the End of Treatment/Early Termination Visit.

Key Inclusion Criteria:

To be eligible for inclusion into the Double-blind Phase of 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 randomization:

- Has completed Worst Itching Intensity NRS worksheets up to 8 days prior to 1st
dose;

- Has a mean baseline Worst Itching Intensity NRS indicative of moderate to severe
uremic pruritus.

- To be eligible for inclusion into the Open-label Extension Phase of the study, each
patient will have to fulfill the additional key following criteria at the time of
entry into the Open-label Extension Phase:

- Has received at least 30 doses of the planned 36 doses of study drug during the
Double-blind Phase of this study;

- Continues to meet inclusion criteria.

Key Exclusion Criteria:

A patient will be excluded from the Double-blind Phase of 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;

- 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;

- Has pruritus only during the dialysis session (by patient report);

- Is receiving ongoing ultraviolet B and anticipates receiving such treatment during the
study;

- Participated in a previous clinical study with CR845.

- A patient will be excluded from the Open-label Extension Phase of the study if any of
the additional key following criteria are met at the time of entry into the Open-label
Extension Phase:

- Completed the Double-blind Phase of this study but exhibited adverse events
during the course of the Treatment Period that may preclude continued exposure to
the study drug;

- Was noncompliant with protocol procedures during the Double-blind Phase of this
study which is indicative of an inability to follow protocol procedures.
We found this trial at
58
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McComb, Mississippi 39648
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Albuquerque, New Mexico 87109
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Bakersfield, California 93309
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Beverly Hills, California 90211
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Bridgeport, Connecticut 06606
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Bronx, New York 10461
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Canton, Ohio 44718
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Chattanooga, Tennessee 37408
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Chesapeake, Virginia 23320
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Chula Vista, California 91910
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Coral Gables, Florida 33134
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Coral Springs, Florida 33071
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Corona, California 92881
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Dallas, Texas 75234
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Denver, Colorado 80218
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Duncanville, Texas 75137
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Durham, North Carolina 27710
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Eatontown, New Jersey 07724
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Escondido, California 92025
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Fair Oaks, California 95628
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Fairfield, California 94533
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Fountain Valley, California 92708
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Fresh Meadows, New York 11365
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Gallup, New Mexico 87301
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Glendale, California 91206
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Great Neck, New York 11021
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Greenville, Texas 75402
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Hampton, Virginia 23666
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Hartford, Connecticut 06112
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Hialeah, Florida 33016
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Homewood, Alabama 35209
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Houston, TX
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Huntsville, Alabama 35805
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Kalamazoo, Michigan 49007
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Kansas City, Missouri 64111
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La Mesa, California 91942
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Lakewood, California 90712
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Las Vegas, Nevada 89144
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Lewisville, Texas 75057
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Long Beach, California 90806
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McAllen, Texas 78503
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Mesquite, Texas 75150
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Miami Gardens, Florida
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107 Elm Street
Middlebury, Connecticut 06762
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Minneapolis, Minnesota 55404
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Ontario, California 91762
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Roseburg, Oregon 97471
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Roseville, California 95661
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Roseville, Michigan 48066
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San Antonio, Texas 78221
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San Diego, California 92123
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San Dimas, California 91773
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Sun Valley, California 91352
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Tampa, Florida 33634
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Tarzana, California 91356
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Tupelo, Mississippi 38801
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Wauwatosa, Wisconsin 53226
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Waxahachie, Texas 75165
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