A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria

NCT03095885 | Completed Results

• 1 other identifier: ALLN-177-204
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Percent of Oxalate Absorption By Test Interval

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

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

  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

Study Arms (1)

Test Meal

OTHER

controlled oxalate-rich test meal

Other: Test Meal

Interventions

Test Meal OTHER

Test Meal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allena Pharmaceuticals: lead

Study Sites (5)

Urological Associates of Southern Arizona, PC

Tucson, Arizona, 85741, United States

Location

Applied Research Center of Arkansas, Inc.

Little Rock, Arkansas, 72212, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Conditions

Nephrolithiasis; Hyperoxaluria; Kidney Calculi; Urologic Diseases; Kidney Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Allena Medical Affairs
• Organization: Allena Pharmaceuticals, Inc

AllenaMedInfo@allenapharma.com

6174674577

Study Officials

• Annamaria Kausz, MD, MS

  Allena Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 30, 2017
• Study Start: November 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 28, 2021
• Results First Posted: March 24, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)