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The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLN-177 | Experimental | ALLN-177 3,750 units per capsule |
|
| Placebo | Placebo Comparator | Placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLN-177 | Drug | ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annamaria Kausz, MD MS | Allena Pharmaceuticals Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Birmingham | Alabama | 35209 | United States | ||
| University of Alabama, Department of Urology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27529510 | Background | 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. | |
| 38319254 | Derived | Lieske 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. |
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| Placebo | Drug | Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days |
|
| 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 |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D006959 | Hyperoxaluria |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000656256 | reloxaliase |
| C021915 | oxalate decarboxylase |
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