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

Prior treatment

• Treatment with tolvaptan, somatostatin analogue, lithium or SGLT2i within the last 3 months before screening
• Known intolerance of the study medication ingredients

Other illness

• Medical history of diabetic ketoacidosis, necrotizing fasciitis or organ transplantation
• Diabetes mellitus type 1 or any type of diabetes mellitus due to insulin deficiency
• Uncontrolled ongoing urinary tract or genital infections
• Uncontrolled grade 2 hypertension (\>160/100 mmHg)
• Primary renal disease other than ADPKD

Lab values

• Hepatic impairment (aspartate transaminase \[AST\] or alanine transaminase \[ALT\]\>3x the up-per limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment)

Other

• Symptomatic hypotension, or systolic blood pressure \<90 mmHg
• Pregnancy, breastfeeding or women of child-bearing potential not using effective contraception method
• Not able to comply with the study protocol, in the investigator's judgement
• Not able to provide informed consent
• Participation in any other interventional clinical trial in the last 2 months

• Male and female patients with ADPKD (modified Ravine criteria) ≥ 18 and ≤ 60 years
• Patients 18 - 39 years: eGFR ≥25 ml/min; patients 40 - 60 years: eGFR ≥25 and \<90 ml/min/1.73 m2
• Indicators of rapid progression, either of the following:
• Mayo class 1D-E
• Mayo class 1C AND EITHER
  • Truncating PKD1 mutation OR
  • eGFR loss \> 3ml/min/year (determined by ≥ 4 creatinine values within 4 years, ≥ 6 months measurement intervals) OR
  • PROPKD score \> 6 (patient history)
• IF patient is on ACE-I /ARBs: stable dose for 4 weeks before screening