Clinical trial NCT03847090: Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
Official title: Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Enteric Hyperoxaluria
Keywords: kidney stone
hyperoxaluria
enteric hyperoxaluria
oxalate
kidney calcification
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-02-20
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Provided informed consent
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:

1. Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30 mL/minute/1.73 m2
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

Primary outcomes:
measure: Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4
timeFrame: 4 weeks
measure: 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)
timeFrame: up to 48 months
Secondary outcomes:
measure: Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24
timeFrame: 24 weeks
measure: Proportion of subjects with a ≥ 20% reduction from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
timeFrame: 4 weeks
measure: Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones
timeFrame: up to 48 months
measure: Change in estimated glomerular filtration rate (eGFR) from baseline
timeFrame: up to 48 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama- Department of Urology
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Mesa
country: United States
facility: Aventiv Research Inc.
state: Arizona
city: Peoria
country: United States
facility: Arizona Kidney Disease and Hypertension Center (AKDHC)- Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Arizona Kidney Disease and Hypertension Center (AKDHC)- Glendale
state: Arizona
city: Phoenix
country: United States
facility: Mayo Mercy Hospital
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Granada Hills
country: United States
facility: Renal Consultants Medical Group
state: California
city: Northridge
country: United States
facility: Amicis Research
state: California
city: San Diego
country: United States
facility: University of California, San Diego (UCSD) Health System
state: California
city: San Francisco
country: United States
facility: University of California- San Francisco (UCSF)
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Vacaville
country: United States
facility: Sutter Health- Sacramento
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Coral Springs
country: United States
facility: South Florida Nephrology Group PA Research Div
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Hialeah
country: United States
facility: Quantum Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Miami Gardens
country: United States
facility: Pro-Care Research Center, Corp
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Idaho Falls
country: United States
facility: Idaho Catalyst Clinical Research
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Carmel
country: United States
facility: IU Health Physicians
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University (IU) Nephrology
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Glen Burnie
country: United States
facility: Chesapeake Urology Associates, LLC d/b/a/ Chesapeake Urology Research Associates
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic- Department of Nephrology Hyperoxaluria Center
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Healthcare
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc
state: Montana
city: Las Vegas
country: United States
facility: Sheldon J. Freedman, MD
state: Nevada
city: Flushing
country: United States
facility: New York Presbyterian/Queens
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: New York
country: United States
facility: New York University School of Medicine- Langone Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) - Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati (UC) - Department of Nephrologyv
state: Ohio
city: Columbus
country: United States
facility: Ohio State University (OSU)-Renal Division
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions- Middleburg Heights
state: Ohio
city: Toledo
country: United States
facility: Genito-Urinary Surgeons
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University (OHSU)
state: Oregon
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center
state: Pennsylvania
city: Providence
country: United States
facility: Lifespan Physician Group Minimally Invasive Urology Institute
state: Rhode Island
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Accelemed Research Institute
state: Texas
city: Dallas
country: United States
facility: Renal Disease Research Institute
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White Research Institute- Temple
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin - Division of Nephrology
state: Wisconsin
city: Wien
country: Austria
facility: Medizinische Universitat Wien, Innere Medizin III
city: Brussels
country: Belgium
facility: UVC Brugmann University Hospital- Centre Hospitalier Universitaire
city: Bruxelles
country: Belgium
facility: Universite Libre de Bruxelles -Hospital Erasme
city: Gent
country: Belgium
facility: University Hospital Gent
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
state: RS
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas da UFMG
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
city: Santo André
country: Brazil
facility: Pesquisare Saude
city: Edmonton
country: Canada
facility: University of Alberta- Division of Urology
state: Alberta
city: Victoria
country: Canada
facility: Silverado Research Inc
state: British Columbia
city: Montréal
country: Canada
facility: Centre de Recherche Du Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Québec
country: Canada
facility: Alpha Recherche Clinique
state: Quebec
city: Zagreb
country: Croatia
facility: Polyclinic Solme
city: Clichy
country: France
facility: Hopital Beaujon_AP_HP
city: Marseille
country: France
facility: AP-HM Hospital de la Conception
city: Paris
country: France
facility: Hospital Tenon-AP-HP
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy-Hopitaux de Brabois
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin- Berlin
city: München
country: Germany
facility: Klinikum der Universitaet- Muenche
city: Firenze
country: Italy
facility: Azienda USL Toscana Centro-Ospedale Santa Maria Nuova
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS - Universita Cattolica del Sacro Cuore
city: Irapuato
country: Mexico
facility: Invesclinic MX
state: Gto, C.P
city: Chihuahua
country: Mexico
facility: ICARO Investigaciones en Medicina SA de CV/Hospital Christus Muguerza
city: Ciudad de mexico
country: Mexico
facility: Centro specializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiovasculares
city: Cuauhtémoc
country: Mexico
facility: Clinstile, S.A. de C.V- Col. Roma Norte Delegacion
city: Amadora
country: Portugal
facility: Hospital Fernando da Fonseca
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao
city: Bucharest
country: Romania
facility: Sana Medical Center
city: Bucharest
country: Romania
facility: Spitalul Clinic Universitar de Urgenta Bucuresti
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Caracal
country: Romania
facility: ClinTrial/County Hospital Caracal
city: Constanţa
country: Romania
facility: Centru de Diagnostic si Tratament Affidea- Medicina Interna
city: Penza
country: Russian Federation
facility: Clinic of Urology LLC
city: Saint Petersburg
country: Russian Federation
facility: LLC Medsi St Petersburg
city: Saint Petersburg
country: Russian Federation
facility: S.M Kirov Military Medical Academy
city: Saint Petersburg
country: Russian Federation
facility: Medical Center "Reavita Med StP" LLC
city: Saint Petersburg
country: Russian Federation
facility: City Hospital #15
city: Saratov
country: Russian Federation
facility: Saratov State Medical University, n.a. V.I. Razumosky
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Girona
country: Spain
facility: Hospital Universitari de Girona
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern Inselspital Bern University Hospital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Nephrology Department
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Dartford
country: United Kingdom
facility: Darent Valley Hospital
city: London
country: United Kingdom
facility: The Royal Free Hospital
city: South Shields
country: United Kingdom
facility: South Tyneside District Hospital - South Shields
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital
Study officials:
affiliation: Allena Pharmaceuticals Inc
name: David Clark, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.