Status:
COMPLETED
Empiric Versus Selective Prevention Strategies for Kidney Stone Disease
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Kidney Stones
Nephrolithiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 a...
Detailed Description
Diet and pharmacologic interventions for preventing future kidney stone episodes are effective, however clinical guideline panels disagree on whether clinicians should perform selective therapy: perfo...
Eligibility Criteria
Inclusion
- Two or more symptomatic kidney stone events in the last 5 years
- Adult
Exclusion
- 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
Key Trial Info
Start Date :
August 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05365477
Start Date
August 4 2022
End Date
October 17 2025
Last Update
October 22 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232