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Clinical Trials in Germany / NCT07280585
Recruiting Phase 3

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

NCT07280585 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2025-12-16
Last updated
2026-07-28

Condition(s) studied

Polycystic Kidney, Autosomal Dominant

Investigational drug(s) / intervention(s)

Dapagliflozin 10 mg →Matching Placebo

Dapagliflozin 10 mg: Participants receive 10 mg of Dapagliflozin orally once daily for 36 months.

Matching Placebo: Participants receive a matching placebo orally once daily for 36 months.

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Vorarlberger Krankenhaus-Betriebsgesellschaft Feldkirch Austria Recruiting
Medizinische Universitaet Innsbruck Innsbruck Austria Recruiting
Robert Bosch Gesellschaft für Medizinische Forschung mbH Stuttgart Baden-Wurttemberg Recruiting
Klinikum Nürnberg Nuremberg Bavaria Not Yet Recruiting
Universitaetsklinikum Aachen AöR Aachen Germany Recruiting
Charite Universitaetsmedizin Berlin KöR Berlin Germany Recruiting
Universitätsklinikum Köln Cologne Germany Recruiting
Klinikum Dortmund gGmbH Dortmund Germany Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Dresden Germany Recruiting
Universitaetsklinikum Duesseldorf AöR Düsseldorf Germany Recruiting
Goethe University Frankfurt Frankfurt Germany Recruiting
Medical Center - University of Freiburg Freiburg im Breisgau Germany Not Yet Recruiting
Universitaetsmedizin Goettingen Göttingen Germany Recruiting
University Medical Center Hamburg-Eppendorf Hamburg Germany Recruiting
Medizinische Hochschule Hannover Hanover Germany Recruiting
Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen Hanover Germany Not Yet Recruiting
Universitaetsklinikum Heidelberg AöR Heidelberg Germany Recruiting
Universitaetsklinikum Jena KöR Jena Germany Recruiting
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany Recruiting
Universitaet Leipzig Leipzig Germany Recruiting
Universitaetsklinikum Schleswig-Holstein AöR Lübeck Germany Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Mainz Germany Recruiting
Klinikum der Technischen Universitaet Muenchen München Germany Recruiting
LMU Klinikum Muenchen AöR München Germany Recruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany Recruiting
Universitair Medisch Centrum Groningen Groningen Netherlands Recruiting
Leids Universitair Medisch Centrum Leiden Netherlands Not Yet Recruiting
Erasmus Universitair Medisch Centrum Rotterdam Rotterdam Netherlands Recruiting
Fundacio Hospital Universitari Vall D'Hebron Institut De Recerca Barcelona Spain Not Yet Recruiting
Fundacio Puigvert Barcelona Spain Not Yet Recruiting

More University of Cologne trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07280585 on ClinicalTrials.gov ↗ ← All trials in Germany