Enteric Hyperoxaluria Clinical Trial
Official title:
Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
| Verified date | February 2020 |
| Source | Allena Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
| Status | Completed |
| Enrollment | 115 |
| Est. completion date | October 28, 2019 |
| Est. primary completion date | September 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Alberta, Division of Urology | Edmonton | Alberta |
| Canada | Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM) | Montréal | Quebec |
| Canada | Research center of CHU de Québec - Université Laval (CHUL) | Québec | Quebec |
| Canada | Toronto Digestive Disease Associates, Inc. | Vaughan | Ontario |
| Canada | Silverado Research Inc | Victoria | British Columbia |
| France | CHU de Nancy-Hopital Brabois | Vandœuvre-lès-Nancy | |
| Germany | Charite Universitaetsmedizin Berlin | Berlin | |
| Germany | Universitaetsklinikum Bonn; Klinik und Poliklinik für Urologie und Kinderurologie | Bonn | |
| Germany | Universitat Bonn - Zentrum für Kinderheilkunde | Bonn | |
| Germany | Universitatsklinikum Freiburg, Klinik for Urologie | Freiburg | |
| Germany | Universitaetsklinikum Leipzig | Leipzig | |
| Germany | PSHI GmbH; PFÜTZNER Science & Health Institute GmbH | Mainz | |
| Germany | Universitat Munchen - Großhadern | Munich | |
| Italy | IRCCS Azienda Ospedaliera Universitaria San Martino IST | Genova | |
| Italy | ASST di Lecco | Lecco | |
| Italy | Azienda Socio-Sanitaria Territoriale di Lecco (ASST di Lecco) | Lecco | |
| Italy | Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore | Rome | |
| Spain | Hospital Universitari de Girona Doctor Josep Trueta | Girona | |
| Spain | Complejo Asistencial de León | León | |
| Spain | Fundacion Jimenez Diaz | Madrid | |
| Spain | Hospital Universitario Infanta Sofia | Madrid | |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
| United Kingdom | The Royal Free Hospital | London | |
| United Kingdom | Freeman Hospital | Newcastle Upon Tyne | |
| United States | TROVARE Clinical Research | Bakersfield | California |
| United States | University of Alabama, Department of Urology | Birmingham | Alabama |
| United States | Urology Centers of Alabama | Birmingham | Alabama |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| 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 | Edmund J. Lewis and Associates | Chicago | Illinois |
| United States | Tristate Urologic Services PSI Inc | Cincinnati | Ohio |
| United States | North Idaho Urology | Coeur d'Alene | Idaho |
| United States | Houston Nephrology Group | Cypress | Texas |
| United States | Renal Disease Research Institute | Dallas | Texas |
| United States | Advanced Urology Institute | Daytona Beach | Florida |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Chesapeake Urology | Hanover | Maryland |
| United States | Houston Metro Urology | Houston | Texas |
| United States | IU Health Physicians | Indianapolis | Indiana |
| United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
| United States | Applied Research Center of Arkansas | Little Rock | Arkansas |
| United States | Center for Advanced GI (CFAGI) | Maitland | Florida |
| United States | Idaho Urologic Institue | Meridian | Idaho |
| United States | South Medical Research Group, Inc. | Miami | Florida |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Columbia University Medical Center | New York | New York |
| United States | Park Avenue Endocrinology & Nutrition | New York | New York |
| United States | The Urology Center, P.C. | Omaha | Nebraska |
| United States | Mayo Clinic Hospital | Phoenix | Arizona |
| United States | Advanced Urology Centers of New York | Plainview | New York |
| United States | Maine Nephrology Associates | Portland | Maine |
| United States | Associated Urologists of North Carolina | Raleigh | North Carolina |
| United States | Virginia Urology | Richmond | Virginia |
| United States | Mayo Clinic-Dept. of Nephrology | Rochester | Minnesota |
| United States | Pen Bay Medical Center | Rockport | Maine |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | University of Utah | Salt Lake City | Utah |
| United States | Regional Urology | Shreveport | Louisiana |
| United States | Genito-Urinary Surgeons | Toledo | Ohio |
| United States | Urological Associates of Southern Arizona | Tucson | Arizona |
| United States | Urology of Virginia | Virginia Beach | Virginia |
| United States | Coastal Urology | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Allena Pharmaceuticals |
United States, Canada, France, Germany, Italy, Spain, United Kingdom,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Proportion of subjects with a = 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4 | 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 | 4 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04629170 -
Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
|
Phase 1 | |
| Recruiting |
NCT05650112 -
Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
|
Phase 1 | |
| Recruiting |
NCT05124886 -
Gut Kidney Axis in Enteric Hyperoxaluria
|
N/A | |
| Completed |
NCT05377112 -
Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome
|
Early Phase 1 | |
| Terminated |
NCT04909723 -
Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
|
Phase 1/Phase 2 | |
| Completed |
NCT03391804 -
Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
|
Phase 2 | |
| Completed |
NCT00588120 -
Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria
|
Phase 1 | |
| Terminated |
NCT03847090 -
Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
|
Phase 3 |