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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Polycystic Kidney, Autosomal Dominant

In brief

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 facts

Study ID

NCT07280585

Run by

University of Cologne

People needed

420

Starts

2025-12-16

Expected to finish

2030-05-15

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Klinikum Der Landeshauptstadt Stuttgart gKAöR — Stuttgart, Germany (enrolling)
• Universitair Medisch Centrum Groningen — Groningen, Netherlands (enrolling)
• Universitaetsklinikum Aachen AöR — Aachen, Germany (enrolling)
• Erasmus Universitair Medisch Centrum Rotterdam — Rotterdam, Netherlands (enrolling)
• Charite Universitaetsmedizin Berlin KöR — Berlin, Germany (enrolling)
• Vorarlberger Krankenhaus-Betriebsgesellschaft — Feldkirch, Austria (enrolling)
• Universitätsklinikum Köln — Cologne, Germany (enrolling)
• Klinikum Dortmund gGmbH — Dortmund, Germany (enrolling)
• Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR — Dresden, Germany (enrolling)
• Universitaetsklinikum Duesseldorf AöR — Düsseldorf, Germany (enrolling)
• Goethe University Frankfurt — Frankfurt, Germany (enrolling)
• Robert Bosch Gesellschaft für Medizinische Forschung mbH — Stuttgart, Baden-Wurttemberg, Germany (enrolling)
• Universitaetsmedizin Goettingen — Göttingen, Germany (enrolling)
• University Medical Center Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Medizinische Hochschule Hannover — Hanover, Germany (enrolling)
• Medizinische Universitaet Innsbruck — Innsbruck, Austria (enrolling)
• Universitaetsklinikum Heidelberg AöR — Heidelberg, Germany (enrolling)
• Universitaetsklinikum Jena KöR — Jena, Germany (enrolling)
• Universitaetsklinikum Schleswig-Holstein AöR — Kiel, Germany (enrolling)
• Universitaet Leipzig — Leipzig, Germany (enrolling)
• Universitaetsklinikum Schleswig-Holstein AöR — Lübeck, Germany (enrolling)
• Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR — Mainz, Germany (enrolling)
• Klinikum der Technischen Universitaet Muenchen — München, Germany (enrolling)
• LMU Klinikum Muenchen AöR — München, Germany (enrolling)
• Fundacio Puigvert — Barcelona, Spain

Full record on ClinicalTrials.gov

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