NCT07280585 STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
| NCT ID | NCT07280585 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Cologne |
| Condition | Polycystic Kidney, Autosomal Dominant |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2030-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 420 participants in total. It began in 2025-12-16 with a primary completion date of 2030-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07280585 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Polycystic Kidney, Autosomal Dominant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07280585 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 420 participants.
Is NCT07280585 currently recruiting?
Yes, NCT07280585 is actively recruiting participants. Contact the research team at STOP-PKD@uk-koeln.de for enrollment information.
Where is the NCT07280585 trial being conducted?
This trial is being conducted at Feldkirch, Austria, Innsbruck, Austria, Stuttgart, Germany, Nuremberg, Germany and 11 additional locations.
Who is sponsoring the NCT07280585 clinical trial?
NCT07280585 is sponsored by University of Cologne. The trial plans to enroll 420 participants.
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