Dapagliflozin to slow kidney function loss in polycystic kidney disease
Tests dapagliflozin against placebo in adults with autosomal dominant polycystic kidney disease.
Plain-language title generated from the registry record
Registry title: STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Key facts
- Where
- Groningen, Leiden, and Rotterdam, NetherlandsSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07280585, who can take part
Where in Netherlands
- Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Cologne
- Trial code
- NCT07280585EU 2025-521276-59-00
- Record updated
- 28 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Treatment with tolvaptan, somatostatin analogue, lithium or SGLT2i within the last 3 months before screening; Known intolerance of the study medication ingredients; 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; 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); 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.