Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

Completed · Phase 2 · Has a placebo group

Conditions studied: Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones, Dietary Hyperoxaluria

In brief

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.

Key facts

Study ID

NCT02547805

Run by

Allena Pharmaceuticals

People needed

66

Starts

2015-09-01

Expected to finish

2017-01-01

Last updated by the study team

2017-01-19

Who can join

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

You may qualify if…

• History of enteric or idiopathic hyperoxaluria or kidney stones
• Urinary oxalate ≥ 50 mg/24 hours

You may not qualify if…

• Hyperuricosuria
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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