Polycystic Kidney, Autosomal DominantPhase 3STOP-PKDNCT07280585
STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
A Phase 3 study testing Dapagliflozin 10 mg in people with Polycystic Kidney, Autosomal Dominant, run by University of Cologne at 30 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Polycystic Kidney, Autosomal Dominant
- What is being tested?
- Dapagliflozin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 16 Dec 2025to 15 May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
30 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 4 countries
Germany23 sites, 23 recruiting
- Recruiting
Universitaetsklinikum Aachen AöR
Aachen
Susanne Fleig, MD, +492418089532, SekretariatMK2@ukaachen.de
- Recruiting
Charite Universitaetsmedizin Berlin KöR
Berlin
Eva Vanessa Schrezenmeier, Dr, +4930450514183, nephrologie-studien@charite.de
- Recruiting
Universitätsklinikum Köln
Cologne
Malte Bartram, Dr., +4922147897222, studienzentrum-medII@uk-koeln.de
- Recruiting
Klinikum Dortmund gGmbH
Dortmund
Fedai Özcan, MD, +4923195321778, studienzentrum@klinikumdo.de
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden
Alexander Paliege, MD, +49351458879, alexander.paliege@ukdd.de
- Recruiting
Universitaetsklinikum Duesseldorf AöR
Düsseldorf
Roman-Ulrich Mueller, Prof., +492118108136, studienzentrum-nephrologie@med.uni-duesseldorf.de
- Recruiting
Goethe University Frankfurt
Frankfurt
Jeannine Lang, MD, +496963015555, sekretariat.nephrologie@unimedizin-ffm.de
- Not yet recruiting
Medical Center - University of Freiburg
Freiburg im Breisgau, 79106
Jan Halbritter, Prof., +4976127032510, jan.halbritter@uniklinik-freiburg.de
- Recruiting
Universitaetsmedizin Goettingen
Göttingen
Oliver Gross, Prof., +495513960400, nephrorheuma.ambulanz@med.uni-goettingen.de
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
Fabian Braun, MD, +4940741050907, nierenambulanz@uke.de
- Recruiting
Medizinische Hochschule Hannover
Hanover
Jessica Kaufeld, MD, +495115323000, studienzentrum@mh-hannover.de
- Not yet recruiting
Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen
Hanover
Georg Schlieper, MD, +49511542630, Ambulanz.Heidering@dialyse-hannover.de
- Recruiting
Universitaetsklinikum Heidelberg AöR
Heidelberg
Claudia Sommerer, Prof., +49622156251449, Studienzentrum-Nephrologie.MED10@med.uni-heidelberg.de
- Recruiting
Universitaetsklinikum Jena KöR
Jena
Martin Busch, Prof., +4936419324391, kim3-nephroambulanz@med.uni-jena.de
- Recruiting
Universitaetsklinikum Schleswig-Holstein AöR
Kiel
Roland Schmitt, Prof., +4943150023062, studienzentrum.nephrologie.kiel@uksh.de
- Recruiting
Universitaet Leipzig
Leipzig
Friederike Petzold, MD, +493419713180, nephrologieambulanz@medizin.uni-leipzig.de
- Recruiting
Universitaetsklinikum Schleswig-Holstein AöR
Lübeck
Figen Cakiroglu, MD, +4945150044351, Franziska.Klingbiel@uksh.de
- Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz
Julia Weinmann-Menke, Prof., +496131176774, julia.weinmann-menke@unimedizin-mainz.de
- Recruiting
Klinikum der Technischen Universitaet Muenchen
München
Lutz Renders, Prof., +498941402231, nephrologie.office@mri.tum.de
- Recruiting
LMU Klinikum Muenchen AöR
München
Michael Fischereder, Prof., +4989440072372, NephroStudien-GH@med.uni-muenchen.de
- Not yet recruiting
Klinikum Nürnberg
Nuremberg, Bavaria, 90471
Christian Morath, Prof., +499113982702
- Recruiting
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Stuttgart, Baden-Wurttemberg, 70376
Joerg Latus, Prof., +4971181015874, andrea.schwab@rbk.de
- Recruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart
Markus Krautter, Dr., +4971127835301, m.krautter@klinikum-stuttgart.de
Netherlands3 sites, 3 recruiting
- Recruiting
Universitair Medisch Centrum Groningen
Groningen
Ron Gansevoort, Prof., +31503616161, researchnefrologie@int.umcg.nl
- Not yet recruiting
Leids Universitair Medisch Centrum
Leiden
Siebe Spijker, MD, +31715262148, researchcoordinator_krig_int@lumc.nl
- Recruiting
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam
Mahdi Salih, MD, +31107040704, tb.ig@erasmusmc.nl
Austria2 sites, 2 recruiting
- Recruiting
Vorarlberger Krankenhaus-Betriebsgesellschaft
Feldkirch
Emanuel Zitt, MD, +4355223032700, nephro@lkhf.at
- Recruiting
Medizinische Universitaet Innsbruck
Innsbruck
Michael Rudnicki, Prof., +435050425855, michael.rudnicki@i-med.ac.at
Spain2 sites, 2 recruiting
- Not yet recruiting
Fundacio Hospital Universitari Vall D'Hebron Institut De Recerca
Barcelona
Laia Sans Axter, MD, +34932746000, assajos.nefrologia@vhir.org
- Not yet recruiting
Fundacio Puigvert
Barcelona
Roser Torra Balcells, Prof., +34934169739, ofgrin@fundacio-puigvert.es
About this study
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.
Read the detailed description
ADPKD is a genetic disease characterized by the growth of fluid-filled renal cysts, leading to progressive loss of kidney function. SGLT2- inhibitors have recently become available for the treatment of chronic kidney disease (CKD). The landmark trials, which proved the positive effect of SGLT2-inhibitors in CKD, excluded patients with ADPKD. Accordingly, current ADPKD-guidelines do not recommend the use of SGLT2-inhibitors in ADPKD.
This investigator-driven, randomized, placebo-controlled, multi-center, double-blind trial will assess the effect of daily dapagliflozin (10mg) intake on the chronic eGFR-slope in 420 patients with ADPKD. As a secondary endpoint the study will assess a composite endpoint triggered by reaching either 40%-eGFR loss, kidney failure or renal death. Safety aspects will additionally be addressed by an interim safety analysis considering total kidney volume, eGFR and copeptin-levels.
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Being tested
- Dapagliflozin 10 mg, Matching Placebo
- Keywords
- STOP-PKD, ADPKD, Dapagliflozin, SGLT2, PKD, polycystic kidney disease, SGLT2i, sodium-glucose, sodium glucose, Phase 3
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 mgDrug
Participants receive 10 mg of Dapagliflozin orally once daily for 36 months.
Matching PlaceboDrug
Participants receive a matching placebo orally once daily for 36 months.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10 mg | Experimental | Not described Receives: Drug: Dapagliflozin 10 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic eGFR slope
The annual chronic eGFR slope will be calculated using all available serum creatinine values from week 6 to week 156 (end of treatment), using linear mixed models.
Measured: week 6 up to week 156 (end of treatment)
Secondary outcomes (5)
Change in eGFR from pre-treatment to post-treatment (off-treatment values)
Change in kidney function will be assessed by comparing the mean eGFR values before treatment (calculated as the average of serum creatinine measurements at week -4 and week 0) with the mean eGFR values after treatment (calculated as the average of measurements at week 162 and week 168). The difference between these two timepoints represents the off-treatment change in kidney function.
Measured: Week -4 to Week 168
Time to first occurrence of a composite renal endpoint
Time from randomization to the first occurrence of any of the following events:
- A sustained ≥40% decrease in eGFR from randomization, confirmed by a second measurement at the next scheduled visit or measured at the last scheduled visit before death or study end.
- End-stage kidney disease (ESKD), defined as initiation of chronic dialysis, kidney transplantation, or a sustained eGFR <15 mL/min/1.73 m².
- Renal death.
Measured: From randomization (week 0) until end of follow-up (up to week 168)
Incidence of serious adverse events (SAEs)
All serious adverse events (SAEs) will be collected.
Measured: From randomization (week 0) until end of follow-up (week 168)
Incidence of adverse events of special interest (AESIs)
All adverse events of special interest (AESIs) will be collected.
Measured: From randomization (week 0) until end of follow-up (week 168)
Change in total kidney volume (TKV) after 1 year
In the first 150 enrolled participants, total kidney volume (TKV) will be measured at baseline and at week 48 using standardized MRI protocols. The change in TKV over 48 weeks will be used to assess potential effects of dapagliflozin on kidney size.
Measured: Baseline (week -4 until week 0) to week 48 (first 150 patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start16 Dec 2025
- Primary completion15 May 2030 (estimated)
- Study completion15 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Kidney, Autosomal DominantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, investigator-driven, multi-center, randomized, placebo-controlled, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Roman Müller, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280585
- Sponsor's protocol ID
- Uni-Koeln-5522
- Other IDs
- 2025-521276-59-00, 2025
- Acronym
- STOP-PKD
- Status last verified
- Jul 2026
- First submitted
- 24 Sep 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muller RU, Guerrot D, Chonchol M, Schmitt R, Uchiyama K, Gansevoort RT, Cornec-Le Gall E. SGLT2 inhibition for patients with ADPKD - closing the evidence gap. Nephrol Dial Transplant. 2025 Nov 26;40(12):2231-2238. doi: 10.1093/ndt/gfaf061.
PubMed 40199734
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT07280585
- Acronym / sponsor ID
- STOP-PKD / Uni-Koeln-5522
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Keywords
- STOP-PKD, ADPKD, Dapagliflozin, SGLT2, PKD, polycystic kidney disease, SGLT2i, sodium-glucose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 15 May 2030 (estimated)
- Study completion
- 15 May 2030 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ADPKD is a genetic disease characterized by the growth of fluid-filled renal cysts, leading to progressive loss of kidney function. SGLT2- inhibitors have recently become available for the treatment of chronic kidney disease (CKD). The landmark trials, which proved the positive effect of SGLT2-inhibitors in CKD, excluded patients with ADPKD. Accordingly, current ADPKD-guidelines do not recommend the use of SGLT2-inhibitors in ADPKD.
This investigator-driven, randomized, placebo-controlled, multi-center, double-blind trial will assess the effect of daily dapagliflozin (10mg) intake on the chronic eGFR-slope in 420 patients with ADPKD. As a secondary endpoint the study will assess a composite endpoint triggered by reaching either 40%-eGFR loss, kidney failure or renal death. Safety aspects will additionally be addressed by an interim safety analysis considering total kidney volume, eGFR and copeptin-levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase III, investigator-driven, multi-center, randomized, placebo-controlled, double-blind
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10 mg | Experimental | Drug: Dapagliflozin 10 mg |
| Placebo | Placebo comparator | Drug: Matching Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 mgParticipants receive 10 mg of Dapagliflozin orally once daily for 36 months. | Drug | Dapagliflozin 10 mg |
| Matching PlaceboParticipants receive a matching placebo orally once daily for 36 months. | Drug | Placebo |
Primary outcome
Chronic eGFR slope
Time frame: week 6 up to week 156 (end of treatment)
The annual chronic eGFR slope will be calculated using all available serum creatinine values from week 6 to week 156 (end of treatment), using linear mixed models.
5 secondary outcomes
Change in eGFR from pre-treatment to post-treatment (off-treatment values)
Time frame: Week -4 to Week 168
Time to first occurrence of a composite renal endpoint
Time frame: From randomization (week 0) until end of follow-up (up to week 168)
Incidence of serious adverse events (SAEs)
Time frame: From randomization (week 0) until end of follow-up (week 168)
Incidence of adverse events of special interest (AESIs)
Time frame: From randomization (week 0) until end of follow-up (week 168)
Change in total kidney volume (TKV) after 1 year
Time frame: Baseline (week -4 until week 0) to week 48 (first 150 patients)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 40199734Muller RU, Guerrot D, Chonchol M, Schmitt R, Uchiyama K, Gansevoort RT, Cornec-Le Gall E. SGLT2 inhibition for patients with ADPKD - closing the evidence gap. Nephrol Dial Transplant. 2025 Nov 26;40(12):2231-2238. doi: 10.1093/ndt/gfaf061.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10 mg in people with Polycystic Kidney, Autosomal Dominant, run by University of Cologne at 30 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, Netherlands, Austria, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roman-Ulrich Müller, Prof. (+49221478191005, STOP-PKD@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic eGFR slope (time frame: week 6 up to week 156 (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07280585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.