Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

NCT05365477 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 200238
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stones; Nephrolithiasis

Keywords

Prevention

Outcome Measures

Primary Outcomes (2)

• Calcium oxalate supersaturation

  Calculated calcium oxalate supersaturation in urine

  Baseline compared to two months

• Calcium phosphate supersaturation

  Calculated calcium phosphate supersaturation in urine

  Baseline compared to two months

Secondary Outcomes (2)

• Uric acid supersaturation

  Baseline compared to two months

• 24hr urine parameters

  Baseline compared to two months

Other Outcomes (6)

• 24hr urine parameters from baseline to month 1

  Baseline to 1 month

• 24hr urine parameters from month 1 to month 2

  1 month to 2 months

• Kidney stone events

  Baseline to 2 months

Study Arms (2)

Empiric Therapy

ACTIVE COMPARATOR

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

Behavioral: Empiric Therapy: Diet; Drug: Empiric Therapy: Drug

Selective Therapy

EXPERIMENTAL

Diet intervention and drug intervention based on 24 hour urine results

Behavioral: Selective Therapy: Diet; Drug: Selective Therapy: Drug

Interventions

Empiric Therapy: Diet BEHAVIORAL

Diet: High water intake - at least 2.5 liters daily Reduce sugar-sweetened cola intake to ≤3 cans per week. Reduce salt intake to \<2000mg sodium daily Reduce red meat intake to two 4-ounce portions per week Normal calcium intake: 3 servings of dairy products (or their equivalents) per day Increase vegetable and fruit intake to ≥5 servings per day Reduce oxalate intake to \<100 mg/day

Empiric Therapy

Empiric Therapy: Drug DRUG

Drug(s): indapamide 1.25mg and potassium citrate 15mEq daily.

Empiric Therapy

Selective Therapy: Diet BEHAVIORAL

Diet: Volume \<2.5L Increase fluid intake to ≥ 2.5L/d, based on specific urine volume Calcium \>250mg male, \>200mg female Reduce red meat intake to two 4-oz portions/wk; reduce sodium intake to\<2000mg/d, avoid vitamin D + calcium supplements Oxalate \>40mg Reduce dietary oxalate intake to \<100 mg/d; increase fiber intake to 25-35 g/d Citrate \<450mg male, \<550mg female Reduce red meat intake to two 4-oz portions/wk; increase fruit and vegetable intake to ≥5 svgs/d pH\<5.8 Reduce red meat intake to two 4-oz portions/wk; increase fruit and vegetable intake to ≥5 svgs/d Uric acid \>800mg male, \>750mg female Reduce red meat intake to two 4- oz portions/wk; increase fruit and vegetable intake to ≥5 svgs/d Sodium \>150mmol Reduce sodium intake to \<2000mg/d Sulfate \> 80mEq or urine urea nitrogen \>14g Reduce red meat intake to three 3-4 oz portions/wk; increase fruit and vegetable intake to ≥5 svgs/d

Selective Therapy

Selective Therapy: Drug DRUG

Drug(s): For calcium \>250mg male, \>200mg female: indapamide 1.25mg and potassium chloride 20mEq. At 1 month if persistent, then increase to indapamide 2.5mg and potassium chloride 20mEq. For citrate \<450mg male, \<550mg female: potassium citrate 15mEq BID. At 1 month if persistent, then increase to potassium citrate 30mEq BID. For pH\<5.8: potassium citrate 15mEq BID. At month if persistent, then increase to potassium citrate 30mEq BID. For uric acid \>800mg male, \>750mg female: allopurinol 300mg. If both elevated calcium and low pH: indapamide 1.25mg and potassium citrate 15mEq BID If both elevated calcium and low citrate: indapamide 1.25mg and potassium citrate 15mEq BID

Selective Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan Hsi, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Urology

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: August 4, 2022
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)