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New treatment option for Polycystic Kidney, Autosomal Dominant
Official title STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
ClinicalTrials.gov ID: NCT07280585
What this study is testing
What is Dapagliflozin 10 mg?
Dapagliflozin 10 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for polycystic kidney, autosomal dominant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
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; 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
You likely can't join if
- 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)
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; 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
- Truncating PKD1 mutation OR
- eGFR loss \> 3ml/min/year (determined by ≥ 4 creatinine values within 4 years, ≥ 6 months measurement intervals) OR
- 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
- 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 treatment clinical trial in the last 2 months
The study team makes the final eligibility decision.
Where it's taking place
- Feldkirch, Austria
- Innsbruck, Austria
- Stuttgart, Baden-Wurttemberg, Germany
- Nuremberg, Bavaria, Germany
- Aachen, Germany
- Berlin, Germany
- Cologne, Germany
- Dortmund, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Frankfurt, Germany
- Freiburg im Breisgau, Germany
- Göttingen, Germany
- Hamburg, Germany
- Hanover, Germany
- Heidelberg, Germany
- Jena, Germany
- Kiel, Germany
- Leipzig, Germany
- Lübeck, Germany
+ 7 more site(s).
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 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Feldkirch, Austria; Innsbruck, Austria; Stuttgart, Baden-Wurttemberg, Germany; Nuremberg, Bavaria, Germany; Aachen, Germany; Berlin, Germany and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.