Spots Global Cancer Trial Database for Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
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Trial Identification
Brief Title: Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
Official Title: A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones
Study ID: NCT02547805
Study Description
Brief Summary: Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.
Detailed Description: This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract. Eligible subjects will be randomized to 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study. The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinica Arizona, Pheonix, Arizona, United States
Urological Associates of Southern Arizona, PC, Tuscon, Arizona, United States
Applied Research Center of Arkansas, Inc., Little Rock, Arkansas, United States
South Florida Medical Research, LLC, Aventura, Florida, United States
Atlantic Urological Associates, Daytona Beach, Florida, United States
Clinical Research Center of Florida, Pompano Beach, Florida, United States
Idaho Urological Institute, Meridian, Idaho, United States
IU Health Physicians Urology, Indianapolis, Indiana, United States
Regional Urology, LLC, Shreveport, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic Department of Medicine Clinical Trials Unit, Rochester, Minnesota, United States
Delaware Valley Urology, LLC, Voorhees, New Jersey, United States
Premier Medical Group of the Hudson Valley, Poughkeepsie, New York, United States
Associated Urologists of North Carolina, Raleigh, North Carolina, United States
Coastal Urology, Wilmington, North Carolina, United States
Tristate Urologic Services PSC INC. DBA The Urology group, Cincinnati, OH, Ohio, United States
Clinical Research Solutions, LLC, Middleburg Heights, Ohio, United States
Omega Medical Research, Warwick, Rhode Island, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology Clinics of North Texas PLLC, Dallas, Texas, United States
Urology of Virginia, Virginia Beach, Virginia, United States
Integrity Medical Research, Mountlake Terrace, Washington, United States
Contact Details
Name: Annamaria Kausz, MD MS
Affiliation: VP Clinical Development
Role: STUDY_DIRECTOR
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