Empiric Versus Selective Prevention Strategies for Kidney Stone Disease
Completed · Phase 4
Conditions studied: Kidney Stones, Nephrolithiasis
In brief
The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.
Key facts
- Study ID
- NCT05365477
- Run by
- Vanderbilt University Medical Center
- People needed
- 56
- Starts
- 2022-08-04
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Two or more symptomatic kidney stone events in the last 5 years
- Adult
You may not qualify if…
- Medullary sponge kidney or renal tubular acidosis
- Untreated urinary obstruction
- Primary hyperparathyroidism
- Primary hyperoxaluria
- Pregnancy
- Inflammatory bowel disease or bowel resection
- Sarcoidosis
- Cystinuria
- Prior stone composition with uric acid, struvite, cystine, carbonate apatite
- Use of specific medications (thiazides, topiramate, xanthine oxidase inhibitors, citrate, bicarbonate)
- Chronic kidney disease stage 3 or higher (eGFR<60)
- Gouty arthritis or 3 gout episodes in 1 year
- Known allergy to study medications
- Hypokalemia or hyponatremia at screening.
- Age < 18 years
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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