Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
1 other identifier
interventional
115
7 countries
63
Brief Summary
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2018
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedStudy Start
First participant enrolled
May 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2019
CompletedFebruary 27, 2020
February 1, 2020
1.4 years
March 1, 2018
February 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
4 weeks
Secondary Outcomes (1)
Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4
4 weeks
Study Arms (2)
ALLN-177
EXPERIMENTALALLN-177 3,750 units per capsule
Placebo
PLACEBO COMPARATORPlacebo capsule
Interventions
Eligibility Criteria
You may qualify if:
- Provided informed consent
- Age 18 or older
- 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)
- Urinary Oxalate ≥ 50mg/24h
You may not qualify if:
- Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73 m2
- Unable or unwilling to discontinue Vitamin C supplementation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Urology Centers of Alabama
Birmingham, Alabama, 35209, United States
University of Alabama, Department of Urology
Birmingham, Alabama, 35294, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Urological Associates of Southern Arizona
Tucson, Arizona, 85715, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
TROVARE Clinical Research
Bakersfield, California, 93301, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Center for Advanced GI (CFAGI)
Maitland, Florida, 32751, United States
South Medical Research Group, Inc.
Miami, Florida, 33186, United States
North Idaho Urology
Coeur d'Alene, Idaho, 83814, United States
Idaho Urologic Institue
Meridian, Idaho, 83642, United States
Edmund J. Lewis and Associates
Chicago, Illinois, 60607, United States
IU Health Physicians
Indianapolis, Indiana, 46202, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Maine Nephrology Associates
Portland, Maine, 04102, United States
Pen Bay Medical Center
Rockport, Maine, 04856, United States
Chesapeake Urology
Hanover, Maryland, 21076, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic-Dept. of Nephrology
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
The Urology Center, P.C.
Omaha, Nebraska, 68114, United States
Park Avenue Endocrinology & Nutrition
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Advanced Urology Centers of New York
Plainview, New York, 11803, United States
Albert Einstein College of Medicine Montefiore Medical Center
The Bronx, New York, 10461, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
Coastal Urology
Wilmington, North Carolina, 28401, United States
Tristate Urologic Services PSI Inc
Cincinnati, Ohio, 45212, United States
Genito-Urinary Surgeons
Toledo, Ohio, 43606, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Houston Nephrology Group
Cypress, Texas, 77429, United States
Renal Disease Research Institute
Dallas, Texas, 75246, United States
Houston Metro Urology
Houston, Texas, 77027, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
University of Alberta, Division of Urology
Edmonton, Alberta, T6G1Z1, Canada
Silverado Research Inc
Victoria, British Columbia, V8T2C1, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4YL, Canada
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, H2X 0A9, Canada
Research center of CHU de Québec - Université Laval (CHUL)
Québec, Quebec, G1L 3L5, Canada
CHU de Nancy-Hopital Brabois
Vandœuvre-lès-Nancy, 54500, France
Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
Universitat Bonn - Zentrum für Kinderheilkunde
Bonn, 53113, Germany
Universitaetsklinikum Bonn; Klinik und Poliklinik für Urologie und Kinderurologie
Bonn, 53127, Germany
Universitatsklinikum Freiburg, Klinik for Urologie
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
PSHI GmbH; PFÜTZNER Science & Health Institute GmbH
Mainz, 55128, Germany
Universitat Munchen - Großhadern
Munich, 81377, Germany
IRCCS Azienda Ospedaliera Universitaria San Martino IST
Genova, 16132, Italy
ASST di Lecco
Lecco, 23800, Italy
Azienda Socio-Sanitaria Territoriale di Lecco (ASST di Lecco)
Lecco, 23900, Italy
Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168, Italy
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007, Spain
Complejo Asistencial de León
León, 24008, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario Infanta Sofia
Madrid, 28702, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
The Royal Free Hospital
London, NW3 2QG, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (2)
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.
PMID: 27529510BACKGROUNDLieske JC, Lingeman JE, Ferraro PM, Wyatt CM, Tosone C, Kausz AT, Knauf F. Randomized Placebo-Controlled Trial of Reloxaliase in Enteric Hyperoxaluria. NEJM Evid. 2022 Jul;1(7):EVIDoa2100053. doi: 10.1056/EVIDoa2100053. Epub 2022 May 6.
PMID: 38319254DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Annamaria Kausz, MD MS
Allena Pharmaceuticals Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2018
First Posted
March 7, 2018
Study Start
May 21, 2018
Primary Completion
September 30, 2019
Study Completion
October 28, 2019
Last Updated
February 27, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share