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

Completed · Phase 2 · Has a placebo group

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

In brief

The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.

Key facts

Study ID

NCT02503345

Run by

Allena Pharmaceuticals

People needed

32

Starts

2015-07-01

Expected to finish

2017-01-01

Last updated by the study team

2018-01-11

Who can join

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

You may qualify if…

• History of enteric or idiopathic hyperoxaluria and at least one kidney stone within the past 2 years
• Hyperoxaluria at screening
• May be taking drugs for the prevention of stone disease

You may not qualify if…

• Hyperuricosuria
• Glomerular filtration rate < 55 mL/min/1.73m2
• Hypercalcemia or hypothyroidism
• Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney
• Treatment with cholestyramine
• Average daily dietary intake of oxalate <75 mg per day

Where it is running

• Tower Urology — Los Angeles, California, United States
• Atlantic Urological Associates — Daytona Beach, Florida, United States
• Mayo Clinic - Nephrology And Hypertension — Jacksonville, Florida, United States
• Northwestern Feinberg School Of Medicine - Urology Department — Chicago, Illinois, United States
• IU Health Physicians Urology — Indianapolis, Indiana, United States
• Anne Arundel Urology — Annapolis, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Brooklyn Urology Research Group — Brooklyn, New York, United States
• North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology — Lake Success, New York, United States
• New York University - Division Of Nephrology — New York, New York, United States
• The Urology Group — Cincinnati, Ohio, United States
• Cleveland Clinic-Urology — Cleveland, Ohio, United States
• Omega Clinical Research — Warwick, Rhode Island, United States
• UT Southwestern Medical Center - Urology — Dallas, Texas, United States
• Urology of Virginia — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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