STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Cologne
About this trial
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.
Eligibility criteria
Qualifiers
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
Mayo class 1D-E
Mayo class 1C AND EITHER
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dapagliflozin 10 mg
- Matching Placebo
Treatment groups
420 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Cologne
Lead sponsor
University Hospital of Cologne
Sponsor institution
German Research Foundation
Collaborator
Source ClinicalTrials.gov