Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

May 23, 2019 updated by: Allena Pharmaceuticals

A Phase 2 Multicenter, Open Label, Single Arm Study Evaluating the Effect of ALLN-177 to Reduce Urinary Oxalate Excretion in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.

Study Type

Interventional

Enrollment (Actual)

16

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
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Physicians Urology
    • New York
      • Lake Success, New York, United States, 11042
        • North Shore Long Island Jewish Health System
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Clinical 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to provide informed consent
  • Able to comply with study procedures
  • History of enteric or idiopathic hyperoxaluria and at least one calcium oxalate kidney stone
  • Hyperoxaluria >36mg of oxalate/24-hr
  • May be taking drugs for the prevention of stone disease as long as there have been no changes in these medications for at least 3 months

Exclusion Criteria:

  • Uric acid ≥1.5g/24-hr
  • Estimated glomerular filtration rate of < 60 mL/min
  • Positive results from drug urine screen
  • Requires daily vitamin C (defined as >10 days of >300 mg/day)
  • Diagnosis of 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.
  • Auto-immune disorder requiring high dose steroids or other immunosuppressant drugs.
  • Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice approved methods of birth control during the trial
  • History of cancer diagnosis except for within the past 5 years excluding dermal squamous and/or basal cell carcinoma or cervical carcinoma in situ.
  • Taken investigational compound within 30 days prior to the first day of the study
  • Treatment with cholestyramine
  • Average daily dietary intake of <75 mg oxalate per day calculated from diet recalls

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ALLN-177

Recurrent Calcium Oxalate Stone Formers with Hyperoxaluria Subjects with Enteric or Idiopathic hyperoxaluria

Dosing: 5 capsules of ALLN-177 orally (p.o.) up to 3 times daily (TID) with meals for 4 consecutive days.
Drug: ALLN-177
ALLN-177 is orally administered oxalate decarboxylase (OxDc). The goal of oral therapy with ALLN-177 is to enzymatically degrade both dietary oxalate and endogenously produced oxalate secreted in the gastrointestinal tract resulting in decreased absorption and reduced urinary oxalate excretion.
Other Names:
  • Oxalate decarboxylase
  • Oxalate degrading enzyme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion
Time Frame: 7 days
Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion
Time Frame: 7 days
Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%
7 days

Collaborators and Investigators

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

Sponsor

Allena Pharmaceuticals

Investigators

  • Study Director: Lee Brettman, MD, FACP, Medical Director

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

September 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (ESTIMATE)

November 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000396

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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