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STOP-PKD: SGLT2-inhibition to improve Prognosis in Polycystic Kidney Disease
EU CTIS ID: 2025-521276-59-00
What this study is testing
The primary objective is to assess whether dapagliflozin improves the decline of kidney function in patients with ADPKD on-treatment (between week 6 and EOT).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female patients with ADPKD (modified Ravine criteria) ≥ 18 and ≤ 60 years
- Patients 18 - 39 years: eGFR ≥25 ml/min/1.73 m2; 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 1. Truncating PKD1 mutation OR 2. eGFR loss > 3ml/min/year (determined by ≥ 4 creatinine values within 4 years, ≥ 6 months measurement intervals) OR 3. PROPKD score > 6 (patient history)
- IF patient is on ACE-I /ARBs: stable dose for 4 weeks before screening
You likely can't join if
- Treatment with tolvaptan, somatostatin analogue, lithium or SGLT2i within the last 3 months before screening
- 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
- Medical history of diabetic ketoacidosis, necrotizing fasciitis or organ transplantation
See the full eligibility criteria
- Male and female patients with ADPKD (modified Ravine criteria) ≥ 18 and ≤ 60 years
- Patients 18 - 39 years: eGFR ≥25 ml/min/1.73 m2; 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 1. Truncating PKD1 mutation OR 2. eGFR loss > 3ml/min/year (determined by ≥ 4 creatinine values within 4 years, ≥ 6 months measurement intervals) OR 3. PROPKD score > 6 (patient history)
- IF patient is on ACE-I /ARBs: stable dose for 4 weeks before screening
- Treatment with tolvaptan, somatostatin analogue, lithium or SGLT2i within the last 3 months before screening
- 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
- 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 upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.