STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Recruiting
Phase 3Interventional Study
Polycystic Kidney, Autosomal Dominant
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
420 (estimated)
Sponsor
University of Cologne · Other
Who this trial is looking for
This trial is looking for adult patients with autosomal dominant polycystic kidney disease (ADPKD) to see if the drug dapagliflozin can help slow kidney function loss. Participants will be monitored to see how their kidney function changes over time.
Are You a Good Fit for This Trial?
Must not be takingTolvaptanSomatostatin analogueLithiumSGLT2 inhibitors
Rules you outDiabetic ketoacidosisNecrotizing fasciitisUncontrolled hypertensionUncontrolled hypotensionHepatic impairment
You may be able to join if
I am between 18 and 60 years old.
I have been diagnosed with autosomal dominant polycystic kidney disease.
I have a certain level of kidney function.
I have signs of rapid disease progression.
I am on stable doses of ACE inhibitors or ARBs if I take them.
You may not be able to join if
I have taken tolvaptan, somatostatin analogue, lithium, or SGLT2 inhibitors in the last 3 months.
I have a history of serious kidney issues or organ transplant.
I have type 1 diabetes or any diabetes due to lack of insulin.
I have ongoing urinary tract or genital infections.
I have uncontrolled high blood pressure.
I am pregnant or breastfeeding, or not using effective contraception.
I cannot follow the study rules.
I cannot give informed consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 …
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
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