Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria

PHASE3TerminatedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

August 26, 2019

Primary Completion Date

May 19, 2022

Study Completion Date

May 19, 2022

Conditions
Enteric Hyperoxaluria
Interventions
DRUG

Reloxaliase

Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day

DRUG

Placebo

Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day

Trial Locations (113)

1020

UVC Brugmann University Hospital- Centre Hospitalier Universitaire, Brussels

1070

Universite Libre de Bruxelles -Hospital Erasme, Brussels

1090

Medizinische Universitat Wien, Innere Medizin III, Vienna

3010

Inselspital, Universitaetsspital Bern Inselspital Bern University Hospital, Bern

10000

Polyclinic Solme, Zagreb

10016

New York University School of Medicine- Langone Medical Center, New York

10117

Charite Universitaetsmedizin- Berlin, Berlin

11023

Long Island Gastrointestinal Research Group, Great Neck

11355

New York Presbyterian/Queens, Flushing

11650

Centro specializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiovasculares, Mexico City

13385

AP-HM Hospital de la Conception, Marseille

14620

University of Rochester, Rochester

16132

IRCCS Azienda Ospedaliera Universitaria San Martino IST, Genova

17007

Hospital Universitari de Girona, Girona

18017

Northeast Clinical Research Center, Bethlehem

21061

Chesapeake Urology Associates, LLC d/b/a/ Chesapeake Urology Research Associates, Glen Burnie

23235

Virginia Urology, Richmond

23462

Urology of Virginia, Virginia Beach

27516

Duke University Medical Center, Durham

27599

University of North Carolina (UNC) - Chapel Hill, Chapel Hill

27612

Associated Urologists of North Carolina, Raleigh

29572

Carolina Urologic Research Center, Myrtle Beach

31000

ICARO Investigaciones en Medicina SA de CV/Hospital Christus Muguerza, Chihuahua City

32224

Mayo Clinic, Jacksonville

32503

Avanza Medical Research Center, Pensacola

32610

University of Florida College of Medicine, Gainesville

33012

Quantum Clinical Research, Hialeah

33014

Pro-Care Research Center, Corp, Miami Gardens

33071

South Florida Nephrology Group PA Research Div, Coral Springs

33606

University of South Florida, Tampa

35234

University of Alabama- Department of Urology, Birmingham

36608

Alliance for Multispecialty Research, LLC, Mobile

36650

Invesclinic MX, Irapuato

37212

Vanderbilt University Medical Center, Nashville

40536

University of Kentucky, Lexington

41013

Hospital Universitario Virgen del Rocio, Seville

43210

Ohio State University (OSU)-Renal Division, Columbus

43606

Genito-Urinary Surgeons, Toledo

44130

Clinical Research Solutions- Middleburg Heights, Middleburg Heights

45267

University of Cincinnati (UC) - Department of Nephrologyv, Cincinnati

46032

IU Health Physicians, Carmel

46202

Indiana University (IU) Nephrology, Indianapolis

48084

University of Michigan, Ann Arbor

50098

Spitalul Clinic Universitar de Urgenta Bucuresti, Bucharest

50122

Azienda USL Toscana Centro-Ospedale Santa Maria Nuova, Florence

52242

University of Iowa, Iowa City

53705

University of Wisconsin - Division of Nephrology, Madison

54500

CHRU de Nancy-Hopitaux de Brabois, Vandœuvre-lès-Nancy

55905

Mayo Clinic- Department of Nephrology Hyperoxaluria Center, Rochester

59808

Montana Medical Research, Inc, Missoula

65211

University of Missouri Healthcare, Columbia

66160

University of Kansas Medical Center, Kansas City

71106

Regional Urology, Shreveport

72211

Arkansas Urology, Little Rock

72212

Applied Research Center of Arkansas, Little Rock

75246

Renal Disease Research Institute, Dallas

75970

Hospital Tenon-AP-HP, Paris

76508

Baylor Scott and White Research Institute- Temple, Temple

77027

Houston Metro Urology, Houston

78229

Urology San Antonio Research, San Antonio

78745

Accelemed Research Institute, Austin

81377

Klinikum der Universitaet- Muenche, München

83404

Idaho Catalyst Clinical Research, Idaho Falls

83642

Idaho Urologic Institute, Meridian

85016

Arizona Kidney Disease and Hypertension Center (AKDHC)- Glendale, Phoenix

85054

Mayo Mercy Hospital, Phoenix

85210

Aventiv Research Inc., Mesa

85381

Arizona Kidney Disease and Hypertension Center (AKDHC)- Phoenix, Peoria

85715

Urological Associates of Southern Arizona, Tucson

85724

Banner University Medical Center, Tucson

89144

Sheldon J. Freedman, MD, Las Vegas

90000

University Hospital Gent, Ghent

91324

Amicis Research, Northridge

91344

Renal Consultants Medical Group, Granada Hills

92103

University of California, San Diego (UCSD) Health System, San Diego

92110

Hopital Beaujon_AP_HP, Clichy

94143

University of California- San Francisco (UCSF), San Francisco

94305

Stanford University School of Medicine, Stanford

95688

Sutter Health- Sacramento, Vacaville

97239

Oregon Health and Science University (OHSU), Portland

191025

LLC Medsi St Petersburg, Saint Petersburg

194044

S.M Kirov Military Medical Academy, Saint Petersburg

194354

"Medical Center Reavita Med StP LLC", Saint Petersburg

198205

City Hospital #15, Saint Petersburg

235200

ClinTrial/County Hospital Caracal, Caracal

410054

Saratov State Medical University, n.a. V.I. Razumosky, Saratov

440026

Clinic of Urology LLC, Penza

900590

Centru de Diagnostic si Tratament Affidea- Medicina Interna, Constanța

06510

Yale University School of Medicine, New Haven

02115

Brigham and Women's Hospital, Boston

02916

Lifespan Physician Group Minimally Invasive Urology Institute, Providence

78229-3900

University of Texas Health Science Center at San Antonio, San Antonio

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

MG-30130-100

Hospital das Clinicas da UFMG, Belo Horizonte

Sp-09060-870

Faculdade de Medicina do ABC, Santo André

SP-09080-110

Pesquisare Saude, Santo André

T6G1Z1

University of Alberta- Division of Urology, Edmonton

V8T2C1

Silverado Research Inc, Victoria

H2X 0A9

Centre de Recherche Du Centre Hospitalier de l'Universite de Montreal, Montreal

G2J 0C4

Alpha Recherche Clinique, Québec

00168

Fondazione Policlinico Universitario A.Gemelli IRCCS - Universita Cattolica del Sacro Cuore, Rome

06700

Clinstile, S.A. de C.V- Col. Roma Norte Delegacion, Cuauhtémoc

2720-276

Hospital Fernando da Fonseca, Amadora

4200-319

Centro Hospitalar Universitario de Sao Joao, Porto

011025

Sana Medical Center, Bucharest

022328

Institutul Clinic Fundeni, Bucharest

08025

Fundacio Puigvert, Barcelona

CH 1011

Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Nephrology Department, Lausanne

CF144XW

University Hospital of Wales, Cardiff

DA2-8DA

Darent Valley Hospital, Dartford

NW3 2QG

The Royal Free Hospital, London

NE34 0PL

South Tyneside District Hospital - South Shields, South Shields

LL13 7TD

Wrexham Maelor Hospital, Wrexham

Sponsors
All Listed Sponsors
lead

Allena Pharmaceuticals

INDUSTRY

NCT03847090 - Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria | Biotech Hunter | Biotech Hunter