Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

Completed · Phase 3 · Has a placebo group

Conditions studied: Enteric Hyperoxaluria

In brief

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

Key facts

Study ID

NCT03456830

Run by

Allena Pharmaceuticals

People needed

115

Starts

2018-05-21

Expected to finish

2019-10-28

Last updated by the study team

2020-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
• Unable or unwilling to discontinue Vitamin C supplementation

Where it is running

• University of Alabama, Department of Urology — Birmingham, Alabama, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Urological Associates of Southern Arizona — Tucson, Arizona, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• TROVARE Clinical Research — Bakersfield, California, United States
• Advanced Urology Institute — Daytona Beach, Florida, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Center for Advanced GI (CFAGI) — Maitland, Florida, United States
• South Medical Research Group, Inc. — Miami, Florida, United States
• North Idaho Urology — Coeur d'Alene, Idaho, United States
• Idaho Urologic Institue — Meridian, Idaho, United States
• Edmund J. Lewis and Associates — Chicago, Illinois, United States
• IU Health Physicians — Indianapolis, Indiana, United States
• Regional Urology — Shreveport, Louisiana, United States
• Maine Nephrology Associates — Portland, Maine, United States
• Pen Bay Medical Center — Rockport, Maine, United States
• Chesapeake Urology — Hanover, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic-Dept. of Nephrology — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The Urology Center, P.C. — Omaha, Nebraska, United States
• Park Avenue Endocrinology & Nutrition — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Advanced Urology Centers of New York — Plainview, New York, United States
• Urology Centers of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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