Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
NCT ID: NCT02547805
Last Updated: 2017-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2015-09-30
2017-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals
Placebo
Placebo 5 capsules PO TID with meals
ALLN-177
Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals
ALLN-177
ALLN-177 7,500 units (5 capsules) PO TID with meals
Interventions
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ALLN-177
ALLN-177 7,500 units (5 capsules) PO TID with meals
Placebo
Placebo 5 capsules PO TID with meals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Urinary oxalate ≥ 50 mg/24 hours
Exclusion Criteria
* Glomerular filtration rate \< 45 mL/min/1.73m2
* Hypercalcemia or hyperthyroidism
* Autoimmune disorder requiring systemic steroids
* Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure
18 Years
ALL
No
Sponsors
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Allena Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Annamaria Kausz, MD MS
Role: STUDY_DIRECTOR
VP Clinical Development
Locations
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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 Township, 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
Countries
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Other Identifiers
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0000713
Identifier Type: -
Identifier Source: org_study_id
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