NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease

RecruitingPhase 3

Sponsor: University of Cologne

Conditions: Polycystic Kidney, Autosomal Dominant

Interventions: Dapagliflozin 10 mg, Matching Placebo

Countries: Austria, Germany, Netherlands, Spain

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (30)

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
Hanover, Germany
Heidelberg, Germany
Jena, Germany
Kiel, Germany
Leipzig, Germany
Lübeck, Germany
Mainz, Germany
München, Germany
München, Germany
Stuttgart, Germany
Groningen, Netherlands
Leiden, Netherlands
Rotterdam, Netherlands
Barcelona, Spain
Barcelona, Spain