Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
- Registration Number
- NCT03847090
- Lead Sponsor
- Allena Pharmaceuticals
- Brief Summary
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.
- Detailed Description
This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 92
- Provided informed consent
- Age 18 years or older
- Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
- Urinary oxalate ≥ 50 mg/24 hr
- Has at least 1 documented kidney stone within 2 years
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2
- Has a known genetic, congenital, or other cause of kidney stones
- Unable or unwilling to discontinue Vitamin C supplementation >200mg daily
- Cannot establish baseline kidney stone burden
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo placebo capsule Reloxaliase Reloxaliase Reloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule
- Primary Outcome Measures
Name Time Method Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4 4 weeks Efficacy will be assessed based on percent change from baseline to the average across Weeks 1 to 4, derived from all 24-hour collections during Weeks 1 to 4 on treatment
Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging) up to 48 months Efficacy will be assessed by comparing kidney stone disease progression event rate on reloxaliase vs. placebo
- Secondary Outcome Measures
Name Time Method Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24 24 weeks Efficacy will be assessed based on percent change from baseline to the average across Weeks 16-24, derived from all 24-hour collections during Weeks 16-24 on treatment
Proportion of subjects with a ≥ 20% reduction from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 4 weeks Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the average across Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones up to 48 months Efficacy will be assessed by comparing utilization on reloxaliase vs. placebo
Change in estimated glomerular filtration rate (eGFR) from baseline up to 48 months Efficacy will be assessed by comparing the rate of change in eGFR on reloxaliase vs. placebo
Trial Locations
- Locations (113)
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Ohio State University (OSU)-Renal Division
🇺🇸Columbus, Ohio, United States
University of California, San Diego (UCSD) Health System
🇺🇸San Diego, California, United States
Darent Valley Hospital
🇬🇧Dartford, United Kingdom
Aventiv Research Inc.
🇺🇸Mesa, Arizona, United States
Alliance for Multispecialty Research, LLC
🇺🇸Mobile, Alabama, 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
Sutter Health- Sacramento
🇺🇸Vacaville, California, United States
Quantum Clinical Research
🇺🇸Hialeah, Florida, United States
South Florida Nephrology Group PA Research Div
🇺🇸Coral Springs, Florida, United States
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
IU Health Physicians
🇺🇸Carmel, Indiana, United States
Indiana University (IU) Nephrology
🇺🇸Indianapolis, Indiana, 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
Montana Medical Research, Inc
🇺🇸Missoula, Montana, United States
Associated Urologists of North Carolina
🇺🇸Raleigh, North Carolina, United States
University of Cincinnati (UC) - Department of Nephrologyv
🇺🇸Cincinnati, Ohio, United States
Clinical Research Solutions- Middleburg Heights
🇺🇸Middleburg Heights, Ohio, United States
Northeast Clinical Research Center
🇺🇸Bethlehem, Pennsylvania, United States
Lifespan Physician Group Minimally Invasive Urology Institute
🇺🇸Providence, Rhode Island, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States
UVC Brugmann University Hospital- Centre Hospitalier Universitaire
🇧🇪Brussels, Belgium
Universite Libre de Bruxelles -Hospital Erasme
🇧🇪Bruxelles, Belgium
University Hospital Gent
🇧🇪Gent, Belgium
Hospital das Clinicas da UFMG
🇧🇷Belo Horizonte, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo André, Brazil
Pesquisare Saude
🇧🇷Santo André, Brazil
Polyclinic Solme
🇭🇷Zagreb, Croatia
Centre de Recherche Du Centre Hospitalier de l'Universite de Montreal
🇨🇦Montréal, Quebec, Canada
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
Azienda USL Toscana Centro-Ospedale Santa Maria Nuova
🇮🇹Firenze, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino IST
🇮🇹Genova, Italy
Klinikum der Universitaet- Muenche
🇩🇪München, Germany
Fondazione Policlinico Universitario A.Gemelli IRCCS - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Spitalul Clinic Universitar de Urgenta Bucuresti
🇷🇴Bucharest, Romania
Institutul Clinic Fundeni
🇷🇴Bucuresti, Romania
ClinTrial/County Hospital Caracal
🇷🇴Caracal, Romania
Centru de Diagnostic si Tratament Affidea- Medicina Interna
🇷🇴Constanţa, Romania
S.M Kirov Military Medical Academy
🇷🇺Saint Petersburg, Russian Federation
Saratov State Medical University, n.a. V.I. Razumosky
🇷🇺Saratov, Russian Federation
Hospital Universitari de Girona
🇪🇸Girona, Spain
Medical Center "Reavita Med StP" LLC
🇷🇺Saint Petersburg, Russian Federation
City Hospital #15
🇷🇺Saint Petersburg, Russian Federation
Fundacio Puigvert
🇪🇸Barcelona, Spain
Inselspital, Universitaetsspital Bern Inselspital Bern University Hospital
🇨🇭Bern, Switzerland
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Nephrology Department
🇨🇭Lausanne, Switzerland
The Royal Free Hospital
🇬🇧London, United Kingdom
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
Banner University Medical Center
🇺🇸Tucson, Arizona, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Arizona Kidney Disease and Hypertension Center (AKDHC)- Glendale
🇺🇸Phoenix, Arizona, United States
Mayo Mercy Hospital
🇺🇸Phoenix, Arizona, United States
University of California- San Francisco (UCSF)
🇺🇸San Francisco, California, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic- Department of Nephrology Hyperoxaluria Center
🇺🇸Rochester, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health and Science University (OHSU)
🇺🇸Portland, Oregon, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, 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
University of Alabama- Department of Urology
🇺🇸Birmingham, Alabama, United States
Arizona Kidney Disease and Hypertension Center (AKDHC)- Phoenix
🇺🇸Peoria, Arizona, United States
Amicis Research
🇺🇸Northridge, California, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Idaho Catalyst Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
University of Missouri Healthcare
🇺🇸Columbia, Missouri, 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
Genito-Urinary Surgeons
🇺🇸Toledo, Ohio, United States
Renal Disease Research Institute
🇺🇸Dallas, Texas, United States
Baylor Scott and White Research Institute- Temple
🇺🇸Temple, Texas, United States
Medizinische Universitat Wien, Innere Medizin III
🇦🇹Wien, Austria
Hospital das Clinicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Silverado Research Inc
🇨🇦Victoria, British Columbia, Canada
Alpha Recherche Clinique
🇨🇦Québec, Quebec, Canada
Charite Universitaetsmedizin- Berlin
🇩🇪Berlin, Germany
ICARO Investigaciones en Medicina SA de CV/Hospital Christus Muguerza
🇲🇽Chihuahua, Mexico
Centro Hospitalar Universitario de Sao Joao
🇵🇹Porto, Portugal
Clinstile, S.A. de C.V- Col. Roma Norte Delegacion
🇲🇽Cuauhtémoc, Mexico
Sana Medical Center
🇷🇴Bucharest, Romania
LLC Medsi St Petersburg
🇷🇺Saint Petersburg, Russian Federation
Clinic of Urology LLC
🇷🇺Penza, Russian Federation
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
South Tyneside District Hospital - South Shields
🇬🇧South Shields, United Kingdom
Pro-Care Research Center, Corp
🇺🇸Miami Gardens, Florida, United States
University of Rochester
🇺🇸Rochester, New York, United States
Wrexham Maelor Hospital
🇬🇧Wrexham, United Kingdom
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Invesclinic MX
🇲🇽Irapuato, Gto, C.P, Mexico
Centro specializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiovasculares
🇲🇽Ciudad de mexico, Mexico
Hospital Fernando da Fonseca
🇵🇹Amadora, Portugal
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
University of North Carolina (UNC) - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Accelemed Research Institute
🇺🇸Austin, Texas, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Wisconsin - Division of Nephrology
🇺🇸Madison, Wisconsin, United States
University of Alberta- Division of Urology
🇨🇦Edmonton, Alberta, Canada
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States