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

January 9, 2018 updated by: Allena Pharmaceuticals

A Phase 2b, Multi-center, Randomized, Double Blind, Placebo-controlled, Crossover Study to Evaluate Multiple Doses of ALLN-177 in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent 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 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for up to 60 subjects.

Study Type

Interventional

Enrollment (Actual)

32

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
    • California
      • Los Angeles, California, United States, 90048
        • Tower Urology
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Nephrology And Hypertension
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Feinberg School Of Medicine - Urology Department
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Physicians Urology
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Urology
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • New York
      • Brooklyn, New York, United States, 11694
        • Brooklyn Urology Research Group
      • Lake Success, New York, United States, 11042
        • North Shore Long Island Jewish Health System/The Arthur Miller Institute for Urology
      • New York, New York, United States, 10016
        • New York University - Division Of Nephrology
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • The Urology Group
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic-Urology
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Clinical Research
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center - Urology
    • Virginia
      • 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

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 and at least one kidney stone within the past 2 years
  • Hyperoxaluria at screening
  • May be taking drugs for the prevention of stone disease

Exclusion Criteria:

  • Hyperuricosuria
  • Glomerular filtration rate < 55 mL/min/1.73m2
  • Hypercalcemia or hypothyroidism
  • Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney
  • Treatment with cholestyramine
  • Average daily dietary intake of oxalate <75 mg per day

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: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsules (1, 2 or 5) PO TID
Drug: Placebo
Placebo: 1, 2 or 5 capsules with meals PO 3 times per day
Experimental: ALLN-177 low dose
ALLN-177 1,500 units/meal PO TID
Drug: ALLN-177 low dose
ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day
Other Names:
  • Oxalate decarboxylase
Experimental: ALLN-177 mid dose
ALLN-177 3,000 units/meal PO TID
Drug: ALLN-177 mid dose
ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day
Other Names:
  • Oxalate decarboxylase
Experimental: ALLN-177 high dose
ALLN-177 7,500 units/meal PO TID
Drug: ALLN-177 high dose
ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day
Other Names:
  • Oxalate decarboxylase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean urinary oxalate excretion (mg/24 h) following treatment
Time Frame: on 7 days of treatment
on 7 days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean urinary oxalate excretion (mg/24 h)
Time Frame: on 7 days of treatment
on 7 days of treatment

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

July 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Actual)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000649

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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