RecruitingPhase 3NCT07280585
STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Sponsor
University of Cologne
Enrollment
420 participants
Start Date
Dec 16, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 60 Years
Inclusion Criteria9
- 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 Criteria13
- Treatment with tolvaptan, somatostatin analogue, lithium or SGLT2i within the last 3 months before screening
- 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
- Known intolerance of the study medication ingredients
- Uncontrolled grade 2 hypertension (\>160/100 mmHg)
- Symptomatic hypotension, or systolic blood pressure \<90 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)
- 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
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Interventions
DRUGDapagliflozin 10 mg
Participants receive 10 mg of Dapagliflozin orally once daily for 36 months.
DRUGMatching Placebo
Participants receive a matching placebo orally once daily for 36 months.
Locations(27)
View Full Details on ClinicalTrials.gov
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NCT07280585