Criteria Checker

Dear visitor to the STOP-PKD website, 

This "inclusion criteria checker" is intended for healthcare professionals and may be used for a preliminary assessment of the possible participation of their patients in the STOP-PKD trial. Not all inclusion and exclusion criteria are explicitly queried—a list of these can be found at the bottom of the page. This tool is explicitly not intended for use by patients. If you are interested in participating, please contact your nephrologist or one of the trial centers.

Inclusion criteria

  • In order to be eligible to participate in this study, a subject must meet all of the following 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 

A potential subject, who meets any of the following criteria, will be excluded from participating in this study: 

  • Treatment with tolvaptan, somatostatin analogue 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 upper 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 (see 9.2.1) 

  • 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