NCT07280585

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

ADPKD is a genetic disease characterized by the growth of fluid-filled renal cysts, leading to progressive loss of kidney function. SGLT2- inhibitors have recently become available for the treatment of chronic kidney disease (CKD). The landmark trials, which proved the positive effect of SGLT2-inhibitors in CKD, excluded patients with ADPKD. Accordingly, current ADPKD-guidelines do not recommend the use of SGLT2-inhibitors in ADPKD. This investigator-driven, randomized, placebo-controlled, multi-center, double-blind trial will assess the effect of daily dapagliflozin (10mg) intake on the chronic eGFR-slope in 420 patients with ADPKD. As a secondary endpoint the study will assess a composite endpoint triggered by reaching either 40%-eGFR loss, kidney failure or renal death. Safety aspects will additionally be addressed by an interim safety analysis considering total kidney volume, eGFR and copeptin-levels.

Conditions

• Polycystic Kidney, Autosomal Dominant

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10 mg	Participants receive 10 mg of Dapagliflozin orally once daily for 36 months.
DRUG	Matching Placebo	Participants receive a matching placebo orally once daily for 36 months.

Timeline

• Start date: 2025-12-16
• Primary completion: 2030-05-15
• Completion: 2030-05-15
• First posted: 2025-12-12
• Last updated: 2026-02-27

Locations

27 sites across 4 countries: Austria, Germany, Netherlands, Spain