Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT02547805
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2015-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D006959', 'term': 'Hyperoxaluria'}, {'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656256', 'term': 'reloxaliase'}, {'id': 'C021915', 'term': 'oxalate decarboxylase'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2015-09-10', 'studyFirstSubmitQcDate': '2015-09-10', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in urinary oxalate excretion (mg/24h)', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Percent change in urinary oxalate excretion', 'timeFrame': '28 days'}, {'measure': '≥ 7.5 mg/24 hr decrease in urinary oxalate', 'timeFrame': '28 days'}, {'measure': '≥ 10 mg/24 hr decrease in urinary oxalate', 'timeFrame': '28 days'}, {'measure': 'Mean change in urinary supersaturation of calcium oxalate', 'timeFrame': '28 days'}, {'measure': 'Time-weighted average urinary oxalate excretion (mg/24h)', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Urine Oxalate', 'Nephrolithiasis', 'Kidney Stones', 'Hyperoxaluria', 'Enteric Hyperoxaluria', 'Idiopathic Hyperoxaluria', 'Urological Diseases', 'Kidney Diseases', 'Supersaturation', 'Dietary Oxalate'], 'conditions': ['Secondary Hyperoxaluria', 'Nephrolithiasis', 'Hyperoxaluria', 'Kidney Stones', 'Dietary Hyperoxaluria']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEligible 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.\n\nThe study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of enteric or idiopathic hyperoxaluria or kidney stones\n* Urinary oxalate ≥ 50 mg/24 hours\n\nExclusion Criteria:\n\n* Hyperuricosuria\n* Glomerular filtration rate \\< 45 mL/min/1.73m2\n* Hypercalcemia or hyperthyroidism\n* Autoimmune disorder requiring systemic steroids\n* Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure'}, 'identificationModule': {'nctId': 'NCT02547805', 'briefTitle': 'Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allena Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones', 'orgStudyIdInfo': {'id': '0000713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ALLN-177', 'description': 'Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals', 'interventionNames': ['Drug: ALLN-177']}], 'interventions': [{'name': 'ALLN-177', 'type': 'DRUG', 'otherNames': ['Oxalate decarboxylase'], 'description': 'ALLN-177 7,500 units (5 capsules) PO TID with meals', 'armGroupLabels': ['ALLN-177']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 5 capsules PO TID with meals', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Pheonix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinica Arizona'}, {'zip': '85741', 'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'Urological Associates of Southern Arizona, PC'}, {'zip': '72212', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Applied Research Center of Arkansas, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Medical Research, LLC', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Atlantic Urological Associates', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33060', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Center of Florida', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Urological Institute', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health Physicians Urology', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Urology, LLC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '555905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Department of Medicine Clinical Trials Unit', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Delaware Valley Urology, LLC', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Premier Medical Group of the Hudson Valley', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Associated Urologists of North Carolina', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Coastal Urology', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '45212', 'city': 'Cincinnati, OH', 'state': 'Ohio', 'country': 'United States', 'facility': 'Tristate Urologic Services PSC INC. DBA The Urology group', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Research Solutions, LLC', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Omega Medical Research', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Urologic Research Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology Clinics of North Texas PLLC', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Urology of Virginia', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98043', 'city': 'Mountlake Terrace', 'state': 'Washington', 'country': 'United States', 'facility': 'Integrity Medical Research', 'geoPoint': {'lat': 47.78815, 'lon': -122.30874}}], 'overallOfficials': [{'name': 'Annamaria Kausz, MD MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VP Clinical Development'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allena Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}