STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Autosomal dominant polycystic kidney disease is the most common genetic cause of kidney failure. The only approved treatment for ADPKD - tolvaptan - is limited in its use by massive therapy-associated polyuria. This trial tests if the SGLT2-inhibitor dapagliflozin slows down the loss of kidney function in ADPKD.
• 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