Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:May 21, 2018
End Date:October 2019
Contact:Allena Pharmaceuticals, Inc
Email:clinical301@allenapharma.com
Phone:617-467-4577

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Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients
with enteric hyperoxaluria.

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This
study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary
oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of
ALLN-177 in this patient population compared to placebo.

Inclusion Criteria:

1. Provided informed consent

2. Age 18 or older

3. History of hyperoxaluria secondary to a known underlying enteric disorder associated
with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or
other malabsorption syndrome)

4. Urinary Oxalate ≥ 50mg/24h

Exclusion Criteria:

1. Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2

2. Unable or unwilling to discontinue Vitamin C supplementation
We found this trial at
38
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Chapel Hill, North Carolina 27599
(919) 962-2211
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Bakersfield, California 93311
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Birmingham, Alabama 35209
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Chicago, Illinois 60607
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Cincinnati, Ohio 45212
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Coeur d'Alene, Idaho 83814
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Dallas, Texas 75235
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545 Health Boulevard
Daytona Beach, Florida 32114
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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11400 University Avenue
Edmonton, Alberta T6G 1Z1
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Hanover, Maryland 21076
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103 East 75th Street
New York, New York 10021
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630 W 168th St
New York, New York
212-305-2862
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