A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

NCT ID: NCT03095885

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-03-31

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Test Meal

controlled oxalate-rich test meal

Group Type: OTHER

Test Meal

Intervention Type: OTHER

Interventions

Test Meal

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allena Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annamaria Kausz, MD, MS

Role: STUDY_DIRECTOR

Allena Pharmaceuticals

Locations

Urological Associates of Southern Arizona, PC

Tucson, Arizona, United States

Applied Research Center of Arkansas, Inc.

Little Rock, Arkansas, United States

Regional Urology, LLC

Shreveport, Louisiana, United States

Omega Medical Research

Warwick, Rhode Island, United States

Urology of Virginia

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

ALLN-177-204

Identifier Type: -

Identifier Source: org_study_id