Clinical trial NCT05365477: Empiric Versus Selective Prevention Strategies for Kidney Stone Disease
Official title: Randomized Trial of Empiric Versus Selective Prevention Strategies for Kidney Stone Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Kidney Stones
Nephrolithiasis
Keywords: Prevention
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 adherence to selective and empiric strategies.

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: performing 24-hour urine testing to guide choosing interventions to correct abnormal urinary parameters. The alternative strategy is empiric therapy: applying interventions without 24-hour urine testing. While 24-hour urine testing is considered the standard of care by nephrology and urology specialties for higher risk patients, the American College of Physicians does not recommend 24-hour urine testing.

This is a randomized clinical trial of selective versus empiric therapy for patients with presumed idiopathic calcium stone disease, representing \>80% of the kidney stone population. The primary outcome is change in urinary supersaturation, which associates with symptomatic stone recurrence. We will recruit patients with presumed idiopathic calcium stone disease with at least 2 stone events within the previous 5 years. Participants will be randomly assigned to empiric diet plus thiazide with potassium citrate daily, or to selective diet plus pharmacologic therapy based on the 24-hour urine abnormalities identified at baseline and adjusted during follow-up. The primary outcomes will be the calculated calcium oxalate and calcium phosphate supersaturations. In addition, we will determine adverse effects from, and adherence to, selective and empiric strategies.

Eligibility criteria: Inclusion Criteria:

* Two or more symptomatic kidney stone events in the last 5 years
* Adult

Exclusion Criteria:

* 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

Primary outcomes:
measure: Calcium oxalate supersaturation
timeFrame: Baseline compared to two months
measure: Calcium phosphate supersaturation
timeFrame: Baseline compared to two months
Secondary outcomes:
measure: Uric acid supersaturation
timeFrame: Baseline compared to two months
measure: 24hr urine parameters
timeFrame: Baseline compared to two months
Other outcomes:
measure: 24hr urine parameters from baseline to month 1
timeFrame: Baseline to 1 month
measure: 24hr urine parameters from month 1 to month 2
timeFrame: 1 month to 2 months
measure: Kidney stone events
timeFrame: Baseline to 2 months
measure: Adverse events
timeFrame: Baseline to 2 months
measure: Diet adherence
timeFrame: Baseline to 2 months
measure: Medication adherence
timeFrame: Baseline to 2 months
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ryan Hsi, MD
role: PRINCIPAL_INVESTIGATOR
References: