Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones
NCT ID: NCT02503345
Last Updated: 2018-01-11
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
32 participants
INTERVENTIONAL
2015-07-31
2017-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo capsules (1, 2 or 5) PO TID
Placebo
Placebo: 1, 2 or 5 capsules with meals PO 3 times per day
ALLN-177 low dose
ALLN-177 1,500 units/meal PO TID
ALLN-177 low dose
ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day
ALLN-177 mid dose
ALLN-177 3,000 units/meal PO TID
ALLN-177 mid dose
ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day
ALLN-177 high dose
ALLN-177 7,500 units/meal PO TID
ALLN-177 high dose
ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day
Interventions
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ALLN-177 low dose
ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day
ALLN-177 mid dose
ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day
ALLN-177 high dose
ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day
Placebo
Placebo: 1, 2 or 5 capsules with meals PO 3 times per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hyperoxaluria at screening
* May be taking drugs for the prevention of stone disease
Exclusion Criteria
* 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
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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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
Countries
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Other Identifiers
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0000649
Identifier Type: -
Identifier Source: org_study_id
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