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NCT05365477 | Recruiting | Kidney Stones


Empiric Versus Selective Prevention Strategies for Kidney Stone Disease
Sponsor:

Vanderbilt University Medical Center

Information provided by (Responsible Party):

Ryan Hsi

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.

Condition or disease

Kidney Stones

Nephrolithiasis

Intervention/treatment

Empiric Therapy: Diet

Empiric Therapy: Drug

Selective Therapy: Diet

Selective Therapy: Drug

Phase

Phase 4

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.}}

Study Type : Interventional
Estimated Enrollment : 56 participants
Masking : Quadruple
Primary Purpose : Prevention
Official Title : Randomized Trial of Empiric Versus Selective Prevention Strategies for Kidney Stone Disease
Actual Study Start Date : August 4, 2022
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025
Arm Intervention/treatment

Active Comparator: Empiric Therapy

Diet intervention and drug intervention not based on 24 hour urine results

Behavioral: Empiric Therapy: Diet

Drug: Empiric Therapy: Drug

Experimental: Selective Therapy

Diet intervention and drug intervention based on 24 hour urine results

Behavioral: Selective Therapy: Diet

Drug: Selective Therapy: Drug

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

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Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

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Locations


Recruiting

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

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