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Clinical Trials in the EU / 2025-521276-59-00
Ongoing Phase III

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

2025-521276-59-00 · tracked via the Priya Life Science EU tracker
Sponsor
University Of Cologne
Sponsor type
Educational Institution
Therapeutic area
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Decision date
06/11/2025
Enrollment target
420
Sites
Netherlands, Austria, Spain, Germany

Condition studied

Autosomal dominant polycystic kidney disease (ADPKD)

Investigational medicinal product(s)

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Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

Annual slope of eGFR decline (in mL/min/1,73m2 per year, chronic slope), as calculated with linear mixed models, using all available creatinine values from week 6 until end of treatment (week 156)

Endpoint detail

Off-treatment values: eGFR change from before to after treatment (using the mean of two creatine measurements for each timepoint; week -4 and 0 for before treatment; week 162 and 168 for follow-up), Composite outcome: Sustained 40 % decrease in eGFR from randomization (confirmed by second measurement in next scheduled visit or measured at the last study follow-up visit / the last scheduled visit before death) • OR ESKD: start of dialysis or kidney transplantation or sustained eGFR <15 mL/min/1.73m2 • OR Renal death, Collection of SAEs and AEs of special interest, Change in total kidney volume after 1 year (first 150 patients; baseline – 48 weeks)

Official registry record

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

View 2025-521276-59-00 on CTIS ↗ ← All trials in the EU