Clinical trial NCT03456830: Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
Official title: Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Enteric Hyperoxaluria
Keywords: Kidney stones
Hyperoxaluria
Enteric hyperoxaluria
Oxalate
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 115
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 and safety of ALLN-177 in patients with enteric hyperoxaluria.

Detailed description: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.

Eligibility criteria: Inclusion Criteria:

1. Provided informed consent
2. Age 18 or older
3. History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
4. Urinary Oxalate ≥ 50mg/24h

Exclusion Criteria:

1. Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73 m2
2. Unable or unwilling to discontinue Vitamin C supplementation

Primary outcomes:
measure: Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama, Department of Urology
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: TROVARE Clinical Research
state: California
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Maitland
country: United States
facility: Center for Advanced GI (CFAGI)
state: Florida
city: Miami
country: United States
facility: South Medical Research Group, Inc.
state: Florida
city: Coeur d'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institue
state: Idaho
city: Chicago
country: United States
facility: Edmund J. Lewis and Associates
state: Illinois
city: Indianapolis
country: United States
facility: IU Health Physicians
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Portland
country: United States
facility: Maine Nephrology Associates
state: Maine
city: Rockport
country: United States
facility: Pen Bay Medical Center
state: Maine
city: Hanover
country: United States
facility: Chesapeake Urology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic-Dept. of Nephrology
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: The Urology Center, P.C.
state: Nebraska
city: Bronx
country: United States
facility: Albert Einstein College of Medicine Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Park Avenue Endocrinology & Nutrition
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Plainview
country: United States
facility: Advanced Urology Centers of New York
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina 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: Wilmington
country: United States
facility: Coastal Urology
state: North Carolina
city: Cincinnati
country: United States
facility: Tristate Urologic Services PSI Inc
state: Ohio
city: Toledo
country: United States
facility: Genito-Urinary Surgeons
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Cypress
country: United States
facility: Houston Nephrology Group
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: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
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: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc.
state: Ontario
city: Montréal
country: Canada
facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
state: Quebec
city: Québec
country: Canada
facility: Research center of CHU de Québec - Université Laval (CHUL)
state: Quebec
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy-Hopital Brabois
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Bonn
country: Germany
facility: Universitat Bonn - Zentrum für Kinderheilkunde
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn; Klinik und Poliklinik für Urologie und Kinderurologie
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg, Klinik for Urologie
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Mainz
country: Germany
facility: PSHI GmbH; PFÜTZNER Science & Health Institute GmbH
city: Munich
country: Germany
facility: Universitat Munchen - Großhadern
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST
city: Lecco
country: Italy
facility: ASST di Lecco
city: Lecco
country: Italy
facility: Azienda Socio-Sanitaria Territoriale di Lecco (ASST di Lecco)
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: León
country: Spain
facility: Complejo Asistencial de León
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: London
country: United Kingdom
facility: The Royal Free Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Allena Pharmaceuticals Inc
name: Annamaria Kausz, MD MS
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.