Clinical trial NCT03095885: A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
Official title: A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-03-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

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.

Primary outcomes:
measure: Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period
timeFrame: 24 hours during baseline and test day following oxalate-rich meal
Secondary outcomes:
measure: Percent of Oxalate Absorption By Test Interval
timeFrame: 0-4 hours post test meal, 0-6 hours post test meal, 0-24 hours post test meal
measure: Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval
timeFrame: 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
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona, PC
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas, Inc.
state: Arkansas
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
Study officials:
affiliation: Allena Pharmaceuticals
name: Annamaria Kausz, MD, MS
role: STUDY_DIRECTOR
References: