Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
NCT ID: NCT03847090
Last Updated: 2022-06-10
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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TERMINATED
PHASE3
92 participants
INTERVENTIONAL
2019-08-26
2022-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Reloxaliase
Reloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule
Reloxaliase
Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
placebo
placebo capsule
Placebo
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day
Interventions
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Reloxaliase
Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
Placebo
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18 years or older
3. Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
4. Urinary oxalate ≥ 50 mg/24 hr
5. Has at least 1 documented kidney stone within 2 years
Exclusion Criteria
2. Has a known genetic, congenital, or other cause of kidney stones
3. Unable or unwilling to discontinue Vitamin C supplementation \>200mg daily
4. Cannot establish baseline kidney stone burden
18 Years
ALL
No
Sponsors
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Allena Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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David Clark, MD
Role: STUDY_DIRECTOR
Allena Pharmaceuticals Inc
Locations
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University of Alabama- Department of Urology
Birmingham, Alabama, United States
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
Aventiv Research Inc.
Mesa, Arizona, United States
Arizona Kidney Disease and Hypertension Center (AKDHC)- Phoenix
Peoria, Arizona, United States
Arizona Kidney Disease and Hypertension Center (AKDHC)- Glendale
Phoenix, Arizona, United States
Mayo Mercy Hospital
Phoenix, Arizona, United States
Urological Associates of Southern Arizona
Tucson, Arizona, United States
Banner University Medical Center
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Renal Consultants Medical Group
Granada Hills, California, United States
Amicis Research
Northridge, California, United States
University of California, San Diego (UCSD) Health System
San Diego, California, United States
University of California- San Francisco (UCSF)
San Francisco, California, United States
Stanford University School of Medicine
Stanford, California, United States
Sutter Health- Sacramento
Vacaville, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
South Florida Nephrology Group PA Research Div
Coral Springs, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Quantum Clinical Research
Hialeah, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Pro-Care Research Center, Corp
Miami Gardens, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
University of South Florida
Tampa, Florida, United States
Idaho Catalyst Clinical Research
Idaho Falls, Idaho, United States
Idaho Urologic Institute
Meridian, Idaho, United States
IU Health Physicians
Carmel, Indiana, United States
Indiana University (IU) Nephrology
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Regional Urology
Shreveport, Louisiana, United States
Chesapeake Urology Associates, LLC d/b/a/ Chesapeake Urology Research Associates
Glen Burnie, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic- Department of Nephrology Hyperoxaluria Center
Rochester, Minnesota, United States
University of Missouri Healthcare
Columbia, Missouri, United States
Montana Medical Research, Inc
Missoula, Montana, United States
Sheldon J. Freedman, MD
Las Vegas, Nevada, United States
New York Presbyterian/Queens
Flushing, New York, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
New York University School of Medicine- Langone Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
University of Cincinnati (UC) - Department of Nephrologyv
Cincinnati, Ohio, United States
Ohio State University (OSU)-Renal Division
Columbus, Ohio, United States
Clinical Research Solutions- Middleburg Heights
Middleburg Heights, Ohio, United States
Genito-Urinary Surgeons
Toledo, Ohio, United States
Oregon Health and Science University (OHSU)
Portland, Oregon, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
Lifespan Physician Group Minimally Invasive Urology Institute
Providence, Rhode Island, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Accelemed Research Institute
Austin, Texas, United States
Renal Disease Research Institute
Dallas, Texas, United States
Houston Metro Urology
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Baylor Scott and White Research Institute- Temple
Temple, Texas, United States
Virginia Urology
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
University of Wisconsin - Division of Nephrology
Madison, Wisconsin, United States
Medizinische Universitat Wien, Innere Medizin III
Vienna, , Austria
UVC Brugmann University Hospital- Centre Hospitalier Universitaire
Brussels, , Belgium
Universite Libre de Bruxelles -Hospital Erasme
Brussels, , Belgium
University Hospital Gent
Ghent, , Belgium
Hospital das Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas da UFMG
Belo Horizonte, , Brazil
Faculdade de Medicina do ABC
Santo André, , Brazil
Pesquisare Saude
Santo André, , Brazil
University of Alberta- Division of Urology
Edmonton, Alberta, Canada
Silverado Research Inc
Victoria, British Columbia, Canada
Centre de Recherche Du Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Alpha Recherche Clinique
Québec, Quebec, Canada
Polyclinic Solme
Zagreb, , Croatia
Hopital Beaujon_AP_HP
Clichy, , France
AP-HM Hospital de la Conception
Marseille, , France
Hospital Tenon-AP-HP
Paris, , France
CHRU de Nancy-Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Charite Universitaetsmedizin- Berlin
Berlin, , Germany
Klinikum der Universitaet- Muenche
München, , Germany
Azienda USL Toscana Centro-Ospedale Santa Maria Nuova
Florence, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino IST
Genova, , Italy
Fondazione Policlinico Universitario A.Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, , Italy
Invesclinic MX
Irapuato, Gto, C.P, Mexico
ICARO Investigaciones en Medicina SA de CV/Hospital Christus Muguerza
Chihuahua City, , Mexico
Clinstile, S.A. de C.V- Col. Roma Norte Delegacion
Cuauhtémoc, , Mexico
Centro specializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiovasculares
Mexico City, , Mexico
Hospital Fernando da Fonseca
Amadora, , Portugal
Centro Hospitalar Universitario de Sao Joao
Porto, , Portugal
Sana Medical Center
Bucharest, , Romania
Institutul Clinic Fundeni
Bucharest, , Romania
Spitalul Clinic Universitar de Urgenta Bucuresti
Bucharest, , Romania
ClinTrial/County Hospital Caracal
Caracal, , Romania
Centru de Diagnostic si Tratament Affidea- Medicina Interna
Constanța, , Romania
Clinic of Urology LLC
Penza, , Russia
LLC Medsi St Petersburg
Saint Petersburg, , Russia
S.M Kirov Military Medical Academy
Saint Petersburg, , Russia
Medical Center "Reavita Med StP" LLC
Saint Petersburg, , Russia
City Hospital #15
Saint Petersburg, , Russia
Saratov State Medical University, n.a. V.I. Razumosky
Saratov, , Russia
Fundacio Puigvert
Barcelona, , Spain
Hospital Universitari de Girona
Girona, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Inselspital, Universitaetsspital Bern Inselspital Bern University Hospital
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Nephrology Department
Lausanne, , Switzerland
University Hospital of Wales
Cardiff, , United Kingdom
Darent Valley Hospital
Dartford, , United Kingdom
The Royal Free Hospital
London, , United Kingdom
South Tyneside District Hospital - South Shields
South Shields, , United Kingdom
Wrexham Maelor Hospital
Wrexham, , United Kingdom
Countries
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References
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Langman CB, Grujic D, Pease RM, Easter L, Nezzer J, Margolin A, Brettman L. A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme. Am J Nephrol. 2016;44(2):150-8. doi: 10.1159/000448766. Epub 2016 Aug 17.
Lingeman JE, Pareek G, Easter L, Pease R, Grujic D, Brettman L, Langman CB. ALLN-177, oral enzyme therapy for hyperoxaluria. Int Urol Nephrol. 2019 Apr;51(4):601-608. doi: 10.1007/s11255-019-02098-1. Epub 2019 Feb 19.
Related Links
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A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme
ALLN-177, oral enzyme therapy for hyperoxaluria
Other Identifiers
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2018-000921-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALLN-177-302
Identifier Type: -
Identifier Source: org_study_id
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