Actively Recruiting
STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Led by University of Cologne · Updated on 2026-02-27
420
Participants Needed
27
Research Sites
230 weeks
Total Duration
On this page
Sponsors
U
University of Cologne
Lead Sponsor
G
German Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients with ADPKD aged 18 to 60 years
- Patients aged 18 to 39 years with eGFR of 25 ml/min or higher
- Patients aged 40 to 60 years with eGFR between 25 and less than 90 ml/min/1.73 m2
- Evidence of rapid disease progression indicated by Mayo class 1D or 1E
- For Mayo class 1C, must have either truncating PKD1 mutation, eGFR loss greater than 3 ml/min per year, or PROPKD score over 6
- Stable dose of ACE-inhibitors or ARBs for at least 4 weeks before screening if currently taking these medications
You will not qualify if you...
- Treatment with tolvaptan, somatostatin analogues, lithium, or SGLT2 inhibitors within 3 months before screening
- History of diabetic ketoacidosis, necrotizing fasciitis, or organ transplantation
- Type 1 diabetes or any insulin-deficient diabetes
- Uncontrolled urinary tract or genital infections
- Known intolerance to study medications
- Uncontrolled grade 2 hypertension (blood pressure over 160/100 mmHg)
- Symptomatic low blood pressure or systolic blood pressure below 90 mmHg
- Kidney diseases other than ADPKD
- Liver impairment with elevated liver enzymes or bilirubin beyond specified limits
- Pregnancy, breastfeeding, or women of child-bearing potential not using effective contraception
- Inability to comply with study protocol or provide informed consent
- Participation in any other interventional clinical trial within 2 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Vorarlberger Krankenhaus-Betriebsgesellschaft
Feldkirch, Austria
Not Yet Recruiting
2
Medizinische Universitaet Innsbruck
Innsbruck, Austria
Not Yet Recruiting
3
Universitaetsklinikum Aachen AöR
Aachen, Germany
Not Yet Recruiting
4
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Not Yet Recruiting
5
Universitätsklinikum Köln
Cologne, Germany
Actively Recruiting
6
Klinikum Dortmund gGmbH
Dortmund, Germany
Not Yet Recruiting
7
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden, Germany
Not Yet Recruiting
8
Universitaetsklinikum Duesseldorf AöR
Düsseldorf, Germany
Not Yet Recruiting
9
Goethe University Frankfurt
Frankfurt, Germany
Not Yet Recruiting
10
Universitaetsmedizin Goettingen
Göttingen, Germany
Not Yet Recruiting
11
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Not Yet Recruiting
12
Medizinische Hochschule Hannover
Hanover, Germany
Not Yet Recruiting
13
Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen
Hanover, Germany
Not Yet Recruiting
14
Universitaetsklinikum Heidelberg AöR
Heidelberg, Germany
Not Yet Recruiting
15
Universitaetsklinikum Jena KöR
Jena, Germany
Not Yet Recruiting
16
Universitaetsklinikum Schleswig-Holstein AöR
Kiel, Germany
Not Yet Recruiting
17
Universitaet Leipzig
Leipzig, Germany
Not Yet Recruiting
18
Universitaetsklinikum Schleswig-Holstein AöR
Lübeck, Germany
Not Yet Recruiting
19
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany
Actively Recruiting
20
Klinikum der Technischen Universitaet Muenchen
München, Germany
Not Yet Recruiting
21
LMU Klinikum Muenchen AöR
München, Germany
Not Yet Recruiting
22
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany
Not Yet Recruiting
23
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Not Yet Recruiting
24
Leids Universitair Medisch Centrum
Leiden, Netherlands
Not Yet Recruiting
25
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands
Not Yet Recruiting
26
Fundacio Hospital Universitari Vall D'Hebron Institut De Recerca
Barcelona, Spain
Not Yet Recruiting
27
Fundacio Puigvert
Barcelona, Spain
Not Yet Recruiting
Research Team
R
Roman-Ulrich Müller, Prof.
CONTACT
P
Philipp Scherrer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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