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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Charité 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 Rocio
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allena Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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