STOP-PKD: SGLT2-inhibition to improve Prognosis in Polycystic Kidney Disease

Trial status: Authorised Off-treatment values: eGFR change from before to after treatment (using the mean of two creatine measurements for each timepoint; week -4 and 0 for before treatment; week 162 and 168 for follow-up), Composite outcome: Sustained 40 % decrease in eGFR from randomization (confirmed by second measurement in next scheduled visit or measured at the last study follow-up visit / the last scheduled visit before death) • OR ESKD: start of dialysis or kidney transplantation or sustained eGFR <15 mL/min/1.73m2 • OR Renal death, Collection of SAEs and AEs of special interest, Change in total kidney volume after 1 year (first 150 patients; baseline – 48 weeks) Annual slope of eGFR decline (in mL/min/1,73m2 per year, chronic slope), as calculated with linear mixed models, using all available creatinine values from week 6 until end of treatment (week 156)

Off-treatment values: eGFR change from before to after treatment (using the mean of two creatine measurements for each timepoint; week -4 and 0 for before treatment; week 162 and 168 for follow-up), Composite outcome: Sustained 40 % decrease in eGFR from randomization (confirmed by second measurement in next scheduled visit or measured at the last study follow-up visit / the last scheduled visit before death) • OR ESKD: start of dialysis or kidney transplantation or sustained eGFR <15 mL/min/1.73m2 • OR Renal death, Collection of SAEs and AEs of special interest, Change in total kidney volume after 1 year (first 150 patients; baseline – 48 weeks)

Age group: 18-64 years Gender: Female, Male Target enrollment: 420 participants