Status:
COMPLETED
Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
Lead Sponsor:
Allena Pharmaceuticals
Conditions:
Enteric Hyperoxaluria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Provided informed consent
- Age 18 or older
- 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)
- Urinary Oxalate ≥ 50mg/24h
Exclusion
- Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73 m2
- Unable or unwilling to discontinue Vitamin C supplementation
Key Trial Info
Start Date :
May 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2019
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT03456830
Start Date
May 21 2018
End Date
October 28 2019
Last Update
February 27 2020
Active Locations (63)
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1
Urology Centers of Alabama
Birmingham, Alabama, United States, 35209
2
University of Alabama, Department of Urology
Birmingham, Alabama, United States, 35294
3
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
4
Urological Associates of Southern Arizona
Tucson, Arizona, United States, 85715