A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
Completed · Not applicable
Conditions studied: Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones
In brief
Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.
Key facts
- Study ID
- NCT03095885
- Run by
- Allena Pharmaceuticals
- People needed
- 22
- Starts
- 2016-11-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2021-10-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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