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

NCT07280585 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-02-27

No results posted yet for this 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.

Conditions

  • Polycystic Kidney, Autosomal Dominant

Interventions

DRUG

Dapagliflozin 10 mg

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

DRUG

Matching Placebo

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

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • University of Cologne

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2030-05-15
Completion
2030-05-15

Countries

  • Austria
  • Germany
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07280585 on ClinicalTrials.gov