Health TrialsbyHealthPanel

CaOx Stone Prevention

ConditionKidney Stones
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

This single-center randomized controlled trial at Mount Sinai West will enroll 80 patients undergoing percutaneous nephrolithotomy for calcium oxalate stones. Participants will be randomized to receive either empiric therapy or selective therapy guided by 24-hour urine evaluation. The primary outcome is change in calcium oxalate supersaturation at 4 weeks, aiming to determine whether empiric therapy can provide outcomes comparable to selective therapy while simplifying access to prevention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult age of 18 years

Diagnosed with kidney stones and scheduled for PCNL.

Calcium Oxalate Stone Former

Pre-operative CT-scan within 90 days of surgery and stone density with > 1000 Hounsfield units

Disqualifiers

Documented history of gastric or intestinal bypass, liver disease, history of gastrointestinal malabsorptive disease (Crohn's disease, ulcerative colitis, and short-gut syndrome)

Hyperparathyroidism -Renal tubular acidosis

Active kidney stone prevention treatment (use of thiazides, alkaline therapy, or low oxalate diet) at the time of surgery

History of hypokalemia or baseline hypotension

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chlorthalidone

    Drug

    Chlorthalidone 25 mg orally once daily is used to reduce urinary calcium excretion and prevent recurrent calcium-containing kidney stones. In this study, it is prescribed either based on stone composition (empiric group) or guided by 24-hour urine results (selective group) for participants meeting criteria for hypercalciuria or calcium oxalate dihydrate stones.

  • Low oxalate diet

    Behavioral

    Participants receive counseling to follow a low oxalate diet, limiting high oxalate foods (\>50 mg/100 g) and restricting moderate oxalate foods (\<50 mg/100 g) to a single four-ounce serving per day. The diet is prescribed either based on stone composition (empiric group) or guided by 24-hour urine results (selective group) for participants with idiopathic hyperoxaluria or calcium oxalate monohydrate stones.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Empiric TherapyExperimental treatment 2 interventions
Group B: Selective TherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Changes in super saturation of calcium oxalate

Change in urine calcium oxalate supersaturation from baseline to the final follow-up visit, measured via 24-hour urine collection. This is a marker that can be predictive of stone episodes, as recurrent stones may take years to develop.

Time frame
4-6 weeks

Secondary outcomes

1

Changes in urinary oxalate levels

Difference in 24-hour urinary oxalate excretion from baseline to the final follow-up visit, measured in mg/day, to assess the effect of dietary and pharmacologic interventions on oxalate levels.

Time frame
4-6 weeks
2

Changes in urinary calcium levels

Difference in 24-hour urinary calcium excretion from baseline to the final follow-up visit, measured in mg/day, to evaluate the effect of chlorthalidone and dietary interventions on urinary calcium levels.

Time frame
4-6 weeks
3

Chlorthalidone Adherence Survey (adapted from Brief Medication Questionnaire)

Participant-reported adherence to prescribed chlorthalidone therapy, assessed via a structured survey at the follow-up visit, to evaluate compliance with the study intervention. Response will be either 0=nonadherent or 1=adherent.

Time frame
4-6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov
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