Nephrolithiasis Clinical Trial
Official title:
A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
NCT number | NCT03095885 |
Other study ID # | ALLN-177-204 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | March 2017 |
Verified date | October 2021 |
Source | Allena Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.
Status | Completed |
Enrollment | 22 |
Est. completion date | March 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Applied Research Center of Arkansas, Inc. | Little Rock | Arkansas |
United States | Regional Urology, LLC | Shreveport | Louisiana |
United States | Urological Associates of Southern Arizona, PC | Tucson | Arizona |
United States | Urology of Virginia | Virginia Beach | Virginia |
United States | Omega Medical Research | Warwick | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Allena Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 0-4 hours post test meal, 0-6 hours post test meal, 0-24 hours post test meal | |
Secondary | 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. | 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 |
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