Randomized, double-blind, placebo-controlled crossover trial assessing the impact of the SGLT2 inhibitor empagliflozin on urinary supersaturations in kidney stone formers (SWEETSTONE)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Clinical trial
• Scope of the study:
  Effectiveness study (incl. comparative)

Clinical trials

• Clinical trial randomisation:
  Randomised clinical trial

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK03) empagliflozin

  empagliflozin
• Medical condition to be studied:
  Nephrolithiasis

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
• Estimated number of subjects:
  46

Study design details

• Main study objective:
  The purpose of this study is to evaluate whether empagliflozin lowers urinary supersaturations as compared to placebo in participants with at least one past episode of kidney stone passage (either spontaneous or removed by urologic intervention).
• Outcomes:
  The primary objective will be addressed by evaluating three primary outcomes. Each of these outcomes will be assessed separately as they reflect different mechanisms and are of potential (clinical) relevance for later trials. • Calcium oxalate supersaturation, • Brushite (calcium phosphate) supersaturation, and • Uric acid supersaturation. Blood: Na, K, Cl, Ca, Mg, P, osmolality, glucose, albumin, creatinine, urea, uric acid, blood gas analysis, 25 hydroxy and 1,25 dihydroxy vitD, PTH, FGF23, HbA1c, lipid panel, TSH. 24 h urine: Na, K, Cl, Ca, Mg, P, osmolality, glucose, protein, albumin, creatinine, urea, uric acid, oxalate, citrate, sulfate, ammonia, bicarbonate, pCO2, pH, calcium
• Data analysis plan:
  Linear mixed effects model will be used for analysis. The mixed effects model will contain the baseline measurements, the 14-days measurements, and an indicator for the treatment and period as fixed effects to adjust for any period effects, and a random effect for participants to account for within-participant correlation of repeated measurements. All primary and secondary endpoints will be analyzed with this approach.