Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

February 25, 2020 updated by: Allena Pharmaceuticals

Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G1Z1
        • University of Alberta, Division of Urology
    • British Columbia
      • Victoria, British Columbia, Canada, V8T2C1
        • Silverado Research Inc
    • Ontario
      • Vaughan, Ontario, Canada, L4L 4YL
        • Toronto Digestive Disease Associates, Inc.
    • Quebec
      • Montréal, Quebec, Canada, H2X 0A9
        • Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
      • Québec, Quebec, Canada, G1L 3L5
        • Research center of CHU de Québec - Université Laval (CHUL)
  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • CHU de Nancy-Hopital Brabois
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin
      • Bonn, Germany, 53113
        • Universitat Bonn - Zentrum für Kinderheilkunde
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn; Klinik und Poliklinik für Urologie und Kinderurologie
      • Freiburg, Germany, 79106
        • Universitatsklinikum Freiburg, Klinik for Urologie
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig
      • Mainz, Germany, 55128
        • PSHI GmbH; PFÜTZNER Science & Health Institute GmbH
      • Munich, Germany, 81377
        • Universitat Munchen - Großhadern
  • Italy
      • Genova, Italy, 16132
        • IRCCS Azienda Ospedaliera Universitaria San Martino IST
      • Lecco, Italy, 23800
        • Asst Di Lecco
      • Lecco, Italy, 23900
        • Azienda Socio-Sanitaria Territoriale di Lecco (ASST di Lecco)
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore
  • Spain
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Doctor Josep Trueta
      • León, Spain, 24008
        • Complejo Asistencial de León
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28702
        • Hospital Universitario Infanta Sofía
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • The Royal Free Hospital
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Urology Centers of Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama, Department of Urology
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
      • Tucson, Arizona, United States, 85715
        • Urological Associates of Southern Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
    • California
      • Bakersfield, California, United States, 93301
        • Trovare Clinical Research
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Advanced Urology Institute
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
      • Maitland, Florida, United States, 32751
        • Center for Advanced GI (CFAGI)
      • Miami, Florida, United States, 33186
        • South Medical Research Group, Inc.
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • North Idaho Urology
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institue
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Edmund J. Lewis and Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Physicians
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Nephrology Associates
      • Rockport, Maine, United States, 04856
        • Pen Bay Medical Center
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Chesapeake Urology
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic-Dept. of Nephrology
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • The Urology Center, P.C.
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine Montefiore Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10021
        • Park Avenue Endocrinology & Nutrition
      • Plainview, New York, United States, 11803
        • Advanced Urology Centers of New York
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27612
        • Associated Urologists of North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Coastal Urology
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Tristate Urologic Services PSI Inc
      • Toledo, Ohio, United States, 43606
        • Genito-Urinary Surgeons
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Cypress, Texas, United States, 77429
        • Houston Nephrology Group
      • Dallas, Texas, United States, 75246
        • Renal Disease Research Institute
      • Houston, Texas, United States, 77027
        • Houston Metro Urology
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Urology
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days
Experimental: ALLN-177
ALLN-177 3,750 units per capsule
Drug: ALLN-177
ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days
Other Names:
  • Oxalate decarboxylase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Time Frame: 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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Time Frame: 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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allena Pharmaceuticals

Investigators

  • Study Director: Annamaria Kausz, MD MS, Allena Pharmaceuticals Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

October 28, 2019

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 27, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ALLN-177-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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