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 |
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.
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.
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
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Utah Research is a major component in the life of the U benefiting...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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