Trial Outcomes & Findings for Pathogenesis of Uric Acid Nephrolithiasis: Role of Pioglitazone/Weight Loss (NCT NCT04370093)

A total of 29 participants were enrolled and signed a consent form. 6 participants out of the 29 enrolled were screen failures. A total of 23 participants were randomized and continued with the study.

Two subjects dropped out after randomization; both were from the "Pioglitazone" group.

24-hour urine pH is the main determinant of uric acid stone formation and recurrence. There is no universally accepted clinical scale for Δ (delta) urine pH like there is for some other biomarkers. In research, Δ urine pH is simply: Δ urine pH = Post-intervention urine pH - Baseline urine pH A practical interpretation commonly used in renal physiology and stone research is: Δ Urine pH Interpretation \< 0 Urine became more acidic 0 to +0.2 No meaningful change * 0.2 to +0.5 Mild alkalinization * 0.5 to +1.0 Moderate alkalinization \> +1.0 Marked alkalinization Higher scores mean a better outcome.

The ratio of urine ammonium to net acid excretion (NH4+/NAE). This is calculated from 24 hr urine ammonium and 24 hr urine net acid excretion. Secondary endpoints include MMRM analysis of weight and urinary stone risk variables. Higher score means positive response.

Urine Net Acid Excretion to Sulphate ratio represents the diet-independent fraction of acid excreted. This is calculated from 24 hr urine net acid excretion and 24 hr urine sulphate.

Supersaturation Index of Uric Acid is a calculated parameters that indicates the degree of urinary saturation with respect to uric acid. There is no universally accepted grading scale (e.g., mild, moderate, severe) for ΔSSI itself. Most studies simply report the numerical change or the percentage change from baseline. When reporting the change in SSI: ΔSSI \< 0 → Improvement (supersaturation decreased) ΔSSI = 0 → No change ΔSSI \> 0 → Worsening (supersaturation increased) There is no minimum or maximum threshold. A lower score indicates better outcome.