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

Sponsor
University of Cologne
Study ID
NCT07280585
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Polycystic Kidney, Autosomal Dominant

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 mg — DRUG
    Participants receive 10 mg of Dapagliflozin orally once daily for 36 months.
  • Matching Placebo — DRUG
    Participants receive a matching placebo orally once daily for 36 months.

Study Details

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.

Key Dates

Start date
Dec 16, 2025
Status verified
Jun 2026
Primary completion
May 15, 2030
Completion
May 15, 2030

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin 10 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Chronic eGFR slope [ Time Frame: week 6 up to week 156 (end of treatment) ]

Central Contacts