Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
- Registration Number
- NCT03456830
- Lead Sponsor
- Allena Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- 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
- Acute renal failure or estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2
- Unable or unwilling to discontinue Vitamin C supplementation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo capsule ALLN-177 ALLN-177 ALLN-177 3,750 units per capsule
- Primary Outcome Measures
Name Time Method Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 4 weeks 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
- Secondary Outcome Measures
Name Time Method 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 mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
Trial Locations
- Locations (63)
Advanced Urology Institute
🇺🇸Daytona Beach, Florida, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States
Pen Bay Medical Center
🇺🇸Rockport, Maine, United States
Associated Urologists of North Carolina
🇺🇸Raleigh, North Carolina, United States
Complejo Asistencial de León
🇪🇸León, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
The Urology Center, P.C.
🇺🇸Omaha, Nebraska, United States
Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Genito-Urinary Surgeons
🇺🇸Toledo, Ohio, United States
Hospital Universitari de Girona Doctor Josep Trueta
🇪🇸Girona, Spain
The Royal Free Hospital
🇬🇧London, United Kingdom
Silverado Research Inc
🇨🇦Victoria, British Columbia, Canada
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Universitario Infanta Sofia
🇪🇸Madrid, Spain
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
TROVARE Clinical Research
🇺🇸Bakersfield, California, United States
Urology Centers of Alabama
🇺🇸Birmingham, Alabama, United States
Coastal Urology
🇺🇸Wilmington, North Carolina, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Park Avenue Endocrinology & Nutrition
🇺🇸New York, New York, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States
Tristate Urologic Services PSI Inc
🇺🇸Cincinnati, Ohio, United States
Houston Nephrology Group
🇺🇸Cypress, Texas, United States
Mayo Clinic-Dept. of Nephrology
🇺🇸Rochester, Minnesota, United States
University of Alabama, Department of Urology
🇺🇸Birmingham, Alabama, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
IU Health Physicians
🇺🇸Indianapolis, Indiana, United States
Edmund J. Lewis and Associates
🇺🇸Chicago, Illinois, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Albert Einstein College of Medicine Montefiore Medical Center
🇺🇸Bronx, New York, United States
University of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Advanced Urology Centers of New York
🇺🇸Plainview, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Renal Disease Research Institute
🇺🇸Dallas, Texas, United States
Universitat Munchen - Großhadern
🇩🇪Munich, Germany
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
Research center of CHU de Québec - Université Laval (CHUL)
🇨🇦Québec, Quebec, Canada
PSHI GmbH; PFÜTZNER Science & Health Institute GmbH
🇩🇪Mainz, Germany
Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Toronto Digestive Disease Associates, Inc.
🇨🇦Vaughan, Ontario, Canada
University of Alberta, Division of Urology
🇨🇦Edmonton, Alberta, Canada
University of Utah
🇺🇸Salt Lake City, Utah, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Chesapeake Urology
🇺🇸Hanover, Maryland, United States
Maine Nephrology Associates
🇺🇸Portland, Maine, United States
Universitat Bonn - Zentrum für Kinderheilkunde
🇩🇪Bonn, Germany
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Center for Advanced GI (CFAGI)
🇺🇸Maitland, Florida, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
🇨🇦Montréal, Quebec, Canada
Universitatsklinikum Freiburg, Klinik for Urologie
🇩🇪Freiburg, Germany
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Charite Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
CHU de Nancy-Hopital Brabois
🇫🇷Vandœuvre-lès-Nancy, France
Universitaetsklinikum Bonn; Klinik und Poliklinik für Urologie und Kinderurologie
🇩🇪Bonn, Germany
ASST di Lecco
🇮🇹Lecco, Italy
Azienda Socio-Sanitaria Territoriale di Lecco (ASST di Lecco)
🇮🇹Lecco, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino IST
🇮🇹Genova, Italy
South Medical Research Group, Inc.
🇺🇸Miami, Florida, United States
Idaho Urologic Institue
🇺🇸Meridian, Idaho, United States