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

NCT07280585 | Recruiting Phase 3 DMC

• 2 other identifiers: Uni-Koeln-55222025-521276-59-00
• Study Type: interventional
• Target: 420
• Locations: 4 countries
• Sites: 27

Brief 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.

Conditions

Polycystic Kidney, Autosomal Dominant

Keywords

STOP-PKD; ADPKD; Dapagliflozin; SGLT2; PKD; polycystic kidney disease; SGLT2i; sodium-glucose; sodium glucose; Phase 3

Outcome Measures

Primary Outcomes (1)

• 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.

  week 6 up to week 156 (end of treatment)

Secondary Outcomes (5)

• Change in eGFR from pre-treatment to post-treatment (off-treatment values)

  Week -4 to Week 168

• Time to first occurrence of a composite renal endpoint

  From randomization (week 0) until end of follow-up (up to week 168)

• Incidence of serious adverse events (SAEs)

  From randomization (week 0) until end of follow-up (week 168)

• Incidence of adverse events of special interest (AESIs)

  From randomization (week 0) until end of follow-up (week 168)

• Change in total kidney volume (TKV) after 1 year

  Baseline (week -4 until week 0) to week 48 (first 150 patients)

Other Outcomes (4)

• Change in kidney function based on cystatin-C measurements

  week -4 until EOS (week 168)

• Changes in albuminuria

  from randomization (week 0) until EOT (week 156)

• Incidence of kidney stones

  from randomization (week 0) until EOS (week 168)

Study Arms (2)

Dapagliflozin 10 mg

EXPERIMENTAL

Drug: Dapagliflozin 10 mg

Placebo

PLACEBO COMPARATOR

Drug: Matching Placebo

Interventions

Dapagliflozin 10 mg DRUG

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

Dapagliflozin 10 mg

Matching Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Cologne: lead
• German Research Foundation: collaborator

Study Sites (27)

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

Related Publications (1)

• 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.

  PMID: 40199734 BACKGROUND

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Polycystic Kidney Diseases

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Central Study Contacts

Roman-Ulrich Müller, Prof.

CONTACT

+491737222719; STOP-PKD@uk-koeln.de

Philipp Scherrer, MD

CONTACT

+491737222719; STOP-PKD@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Phase III, investigator-driven, multi-center, randomized, placebo-controlled, double-blind

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 12, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): May 15, 2030
• Study Completion (Estimated): May 15, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (20); NL (3); AU (2); ES (2)