Dapagliflozin to slow kidney decline in autosomal dominant polycystic kidney disease
STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
This will test if taking dapagliflozin every day slows kidney function loss in adults 18–60 with rapidly progressing ADPKD.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Cologne Academic / other |
| Locations | 27 sites (Feldkirch and 26 other locations) |
| Trial ID | NCT07280585 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial that will enroll 420 adults with rapidly progressing autosomal dominant polycystic kidney disease to receive dapagliflozin 10 mg daily or matching placebo. The primary outcome is the chronic eGFR slope over follow-up, and a secondary composite endpoint includes a 40% eGFR loss, kidney failure, or renal death. Safety will be monitored with an interim analysis including total kidney volume, eGFR, and copeptin levels. Key exclusions include recent use of tolvaptan, SGLT2 inhibitors, somatostatin analogues, or certain serious infections and diabetes types that confer higher risk.
Who should consider this trial
Good fit: Adults 18–60 with ADPKD who meet rapid-progression criteria (Mayo class 1D–E, or 1C plus high-risk genetics, rapid eGFR loss, or high PROPKD score) and have eGFR ≥25 ml/min (and <90 ml/min for ages 40–60) are ideal candidates.
Not a fit: Patients with eGFR below 25 ml/min, age over 60, type 1 diabetes or insulin-deficient diabetes, recent tolvaptan/SGLT2i use, active uncontrolled urinary/genital infections, or certain prior serious infections or transplants are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, dapagliflozin could slow eGFR decline and delay progression to kidney failure in patients with ADPKD.
How similar studies have performed: Large landmark trials have shown SGLT2 inhibitors benefit chronic kidney disease broadly, but those trials excluded ADPKD patients, so direct evidence in ADPKD is presently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 1. Truncating PKD1 mutation OR 2. eGFR loss \> 3ml/min/year (determined by ≥ 4 creatinine values within 4 years, ≥ 6 months measurement intervals) OR 3. PROPKD score \> 6 (patient history) * IF patient is on ACE-I /ARBs: stable dose for 4 weeks before screening Exclusion Criteria: * 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 this trial is running
Feldkirch and 26 other locations
- Vorarlberger Krankenhaus-Betriebsgesellschaft — Feldkirch, Austria (Not_yet_recruiting)
- Medizinische Universitaet Innsbruck — Innsbruck, Austria (Not_yet_recruiting)
- Universitaetsklinikum Aachen AöR — Aachen, Germany (Not_yet_recruiting)
- Charite Universitaetsmedizin Berlin KöR — Berlin, Germany (Not_yet_recruiting)
- Universitätsklinikum Köln — Cologne, Germany (Recruiting)
- Klinikum Dortmund gGmbH — Dortmund, Germany (Not_yet_recruiting)
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR — Dresden, Germany (Not_yet_recruiting)
- Universitaetsklinikum Duesseldorf AöR — Düsseldorf, Germany (Not_yet_recruiting)
- Goethe University Frankfurt — Frankfurt, Germany (Not_yet_recruiting)
- Universitaetsmedizin Goettingen — Göttingen, Germany (Not_yet_recruiting)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Not_yet_recruiting)
- Medizinische Hochschule Hannover — Hanover, Germany (Not_yet_recruiting)
- Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen — Hanover, Germany (Not_yet_recruiting)
- Universitaetsklinikum Heidelberg AöR — Heidelberg, Germany (Not_yet_recruiting)
- Universitaetsklinikum Jena KöR — Jena, Germany (Not_yet_recruiting)
- Universitaetsklinikum Schleswig-Holstein AöR — Kiel, Germany (Not_yet_recruiting)
- Universitaet Leipzig — Leipzig, Germany (Not_yet_recruiting)
- Universitaetsklinikum Schleswig-Holstein AöR — Lübeck, Germany (Not_yet_recruiting)
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR — Mainz, Germany (Recruiting)
- Klinikum der Technischen Universitaet Muenchen — München, Germany (Not_yet_recruiting)
- LMU Klinikum Muenchen AöR — München, Germany (Not_yet_recruiting)
- Klinikum Der Landeshauptstadt Stuttgart gKAöR — Stuttgart, Germany (Not_yet_recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Not_yet_recruiting)
- Leids Universitair Medisch Centrum — Leiden, Netherlands (Not_yet_recruiting)
- Erasmus Universitair Medisch Centrum Rotterdam — Rotterdam, Netherlands (Not_yet_recruiting)
- Fundacio Hospital Universitari Vall D'Hebron Institut De Recerca — Barcelona, Spain (Not_yet_recruiting)
- Fundacio Puigvert — Barcelona, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Roman-Ulrich Müller, Prof.
- Email: STOP-PKD@uk-koeln.de
- Phone: +491737222719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.