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A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

Primary Purpose

Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Test Meal

About this trial

This is an interventional basic science trial for Secondary Hyperoxaluria focused on measuring Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, urological Diseases, Kidney Diseases, Dietary Oxalate, Idiopathic Hyperoxaluria, Oxalate Absorption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or non-pregnant and non-lactating females
History of hyperoxaluria secondary to a known underlying enteric disease (e.g., Crohn's disease, bariatric surgery, and others) or without a known underlying cause (idiopathic), and kidney stones.
Urinary oxalate ≥ 40 mg of oxalate/24 hr at screening.
If taking drugs for the prevention of stone disease, including pyridoxine, thiazides (chlorthalidone, hydrochlorothiazide, and indapamide), citrate supplements, and allopurinol, there must have been no changes in these medications for at least one month prior to screening and no changes are anticipated for the duration of the study.
Able to understand and provide written informed consent.

Exclusion Criteria:

Under or over-collection on screening 24-hour urine collection (mg creatinine/kg body weight outside of gender-specific range).
Estimated glomerular filtration rate (eGFR) <40 mL/minute/1.73 m^2 or acute renal failure.
Primary hyperoxaluria.
Allergy, intolerance, or any other factors limiting ability to consume the study foods or adhere to the study meal schedule.
Positive pregnancy test during Screening.
Clinically significant findings (including acute renal colic), an ongoing clinically significant illness requiring changes in management, or any planned medical/surgical procedure during the study.
Malignancy undergoing active therapy; patients in remission on chronic suppressive or maintenance therapies are not excluded.
Investigational compound within 30 days prior to screening.
Investigator determined that the subject would not be able to adhere or to complete the study procedures , or could not discontinue Vitamin C supplements, calcium supplements, or other medications that could interfere with oxalate absorption and/or excretion.

Sites / Locations

Urological Associates of Southern Arizona, PC
Applied Research Center of Arkansas, Inc.
Regional Urology, LLC
Omega Medical Research
Urology of Virginia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Test Meal

Arm Description

controlled oxalate-rich test meal

Outcomes

Primary Outcome Measures

Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period

Percent of oxalate absorption normalized by baseline was calculated by 100*[UOx/test - UOx/baseline]/Ox intake from the test meal.

Secondary Outcome Measures

Percent of Oxalate Absorption By Test Interval

Percent of Oxalate absorption by test interval was calculated as the urinary oxalate excretions (mg) during the test interval divided by the amount of oxalate in the test meal.

Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval

Urinary oxalate (UOx) excretion was normalized to units of mg/g creatinine by dividing the UOx in mg by the creatinine value in g from the same collection. Percent change from baseline for UOx/Cr from Baseline was calculated by 100 * [UOx/Cr for the test interval - UOx/Cr at Baseline] / UOx/Cr at Baseline.

Full Information

NCT ID

NCT03095885

First Posted

March 20, 2017

Last Updated

October 5, 2021

Sponsor

Allena Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03095885

Brief Title

A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

Official Title

A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allena Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.

Detailed Description

This was a prospective 4-day study of oxalate absorption in subjects with secondary hyperoxaluria. Subjects visited the research center three times for outpatient visits (Screening, Test Day 3, Day 4). Subjects were instructed to follow a low-oxalate diet, consuming only study-specified food choices that had low or no oxalate and controlled calcium content Days 1 through 4 (Baseline Period through the Day 4 clinic visit) and, on Test Day 3, consumed an oxalate-rich test meal. Subjects performed three 24-hour urine collections during Screening, Baseline Day 2, and Test Day 3. Test Day 3 included the oxalate-rich test meal and the subject collected a 24-hour urine separated into 4 urine collection intervals. (Pre-test meal, post-test meal to 4 hours, 4-6 hours post test meal and remaining time to complete 24 hours).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones

Keywords

Urine Oxalate, Nephrolithiasis, Kidney Stones, Hyperoxaluria, Enteric Hyperoxaluria, urological Diseases, Kidney Diseases, Dietary Oxalate, Idiopathic Hyperoxaluria, Oxalate Absorption

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Meal

Arm Type

Other

Arm Description

controlled oxalate-rich test meal

Intervention Type

Other

Intervention Name(s)

Test Meal

Primary Outcome Measure Information:

Title

Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period

Description

Percent of oxalate absorption normalized by baseline was calculated by 100*[UOx/test - UOx/baseline]/Ox intake from the test meal.

Time Frame

24 hours during baseline and test day following oxalate-rich meal

Secondary Outcome Measure Information:

Title

Percent of Oxalate Absorption By Test Interval

Description

Percent of Oxalate absorption by test interval was calculated as the urinary oxalate excretions (mg) during the test interval divided by the amount of oxalate in the test meal.

Time Frame

0-4 hours post test meal, 0-6 hours post test meal, 0-24 hours post test meal

Title

Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval

Description

Time Frame

24 hours during baseline, 0 to 4 hours post test meal, 0-6 hours post test meal, 6-24 hours post test meal, 0-24 hours post test meal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or non-pregnant and non-lactating females History of hyperoxaluria secondary to a known underlying enteric disease (e.g., Crohn's disease, bariatric surgery, and others) or without a known underlying cause (idiopathic), and kidney stones. Urinary oxalate ≥ 40 mg of oxalate/24 hr at screening. If taking drugs for the prevention of stone disease, including pyridoxine, thiazides (chlorthalidone, hydrochlorothiazide, and indapamide), citrate supplements, and allopurinol, there must have been no changes in these medications for at least one month prior to screening and no changes are anticipated for the duration of the study. Able to understand and provide written informed consent. Exclusion Criteria: Under or over-collection on screening 24-hour urine collection (mg creatinine/kg body weight outside of gender-specific range). Estimated glomerular filtration rate (eGFR) <40 mL/minute/1.73 m^2 or acute renal failure. Primary hyperoxaluria. Allergy, intolerance, or any other factors limiting ability to consume the study foods or adhere to the study meal schedule. Positive pregnancy test during Screening. Clinically significant findings (including acute renal colic), an ongoing clinically significant illness requiring changes in management, or any planned medical/surgical procedure during the study. Malignancy undergoing active therapy; patients in remission on chronic suppressive or maintenance therapies are not excluded. Investigational compound within 30 days prior to screening. Investigator determined that the subject would not be able to adhere or to complete the study procedures , or could not discontinue Vitamin C supplements, calcium supplements, or other medications that could interfere with oxalate absorption and/or excretion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annamaria Kausz, MD, MS

Organizational Affiliation

Allena Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Urological Associates of Southern Arizona, PC

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

Applied Research Center of Arkansas, Inc.

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72212

Country

United States

Facility Name

Regional Urology, LLC

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71106

Country

United States

Facility Name

Omega Medical Research

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Urology of Virginia

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23462

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

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