Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days

January 17, 2017 updated by: Allena Pharmaceuticals

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones

Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.

Eligible subjects will be randomized to 28 days of treatment with ALLN-177 (7,500 units) or placebo three times daily with meals. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for approximately 66 subjects. The number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

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

  • United States
    • Arizona
      • Pheonix, Arizona, United States, 85054
        • Mayo Clinica Arizona
      • Tuscon, Arizona, United States, 85741
        • Urological Associates of Southern Arizona, PC
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas, Inc.
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research, LLC
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Pompano Beach, Florida, United States, 33060
        • Clinical Research Center of Florida
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Urological Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Physicians Urology
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 555905
        • Mayo Clinic Department of Medicine Clinical Trials Unit
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Delaware Valley Urology, LLC
    • New York
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Associated Urologists of North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Coastal Urology
    • Ohio
      • Cincinnati, OH, Ohio, United States, 45212
        • TriState Urologic Services PSC Inc. DBA The Urology Group
      • Middleburg Heights, Ohio, United States, 44130
        • Clinical Research Solutions, LLC
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas PLLC
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Integrity Medical Research

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of enteric or idiopathic hyperoxaluria or kidney stones
  • Urinary oxalate ≥ 50 mg/24 hours

Exclusion Criteria:

  • Hyperuricosuria
  • Glomerular filtration rate < 45 mL/min/1.73m2
  • Hypercalcemia or hyperthyroidism
  • Autoimmune disorder requiring systemic steroids
  • Acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Five (5) capsules of placebo by mouth (PO) three times per day (TID) with meals
Drug: Placebo
Placebo 5 capsules PO TID with meals
Experimental: ALLN-177
Five (5) capsules of ALLN-177 (1,500 units per capsule) PO TID with meals
Drug: ALLN-177
ALLN-177 7,500 units (5 capsules) PO TID with meals
Other Names:
  • Oxalate decarboxylase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in urinary oxalate excretion (mg/24h)
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in urinary oxalate excretion
Time Frame: 28 days
28 days
≥ 7.5 mg/24 hr decrease in urinary oxalate
Time Frame: 28 days
28 days
≥ 10 mg/24 hr decrease in urinary oxalate
Time Frame: 28 days
28 days
Mean change in urinary supersaturation of calcium oxalate
Time Frame: 28 days
28 days
Time-weighted average urinary oxalate excretion (mg/24h)
Time Frame: 28 days
28 days

Collaborators and Investigators

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

Sponsor

Allena Pharmaceuticals

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

September 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000713

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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