Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones
- Conditions
- Secondary HyperoxaluriaNephrolithiasisDietary HyperoxaluriaKidney StonesHyperoxaluria
- Interventions
- Drug: PlaceboDrug: ALLN-177 high doseDrug: ALLN-177 mid doseDrug: ALLN-177 low dose
- Registration Number
- NCT02503345
- Lead Sponsor
- Allena Pharmaceuticals
- Brief Summary
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.
- 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 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.
The study allows for up to 60 subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo capsules (1, 2 or 5) PO TID ALLN-177 high dose ALLN-177 high dose ALLN-177 7,500 units/meal PO TID ALLN-177 mid dose ALLN-177 mid dose ALLN-177 3,000 units/meal PO TID ALLN-177 low dose ALLN-177 low dose ALLN-177 1,500 units/meal PO TID
- Primary Outcome Measures
Name Time Method Mean urinary oxalate excretion (mg/24 h) following treatment on 7 days of treatment
- Secondary Outcome Measures
Name Time Method Change from baseline in mean urinary oxalate excretion (mg/24 h) on 7 days of treatment
Trial Locations
- Locations (16)
North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology
🇺🇸Lake Success, New York, United States
Northwestern Feinberg School Of Medicine - Urology Department
🇺🇸Chicago, Illinois, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Tower Urology
🇺🇸Los Angeles, California, United States
Atlantic Urological Associates
🇺🇸Daytona Beach, Florida, United States
Mayo Clinic - Nephrology And Hypertension
🇺🇸Jacksonville, Florida, United States
Anne Arundel Urology
🇺🇸Annapolis, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brooklyn Urology Research Group
🇺🇸Brooklyn, New York, United States
New York University - Division Of Nephrology
🇺🇸New York, New York, 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
IU Health Physicians Urology
🇺🇸Indianapolis, Indiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States