Criteria Checker

Dear visitor to the STOP-PKD website, 

This "inclusion criteria checker" is intended for healthcare professionals and is designed to provide an initial, preliminary assessment of whether your patients may be eligible to take part 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 treating nephrology practice or one of the trial centres. 

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 disease progression, i.e. one of the following conditions: 

  • Mayo class 1D-E 

  • Mayo class 1C AND EITHER  

  1. Truncating PKD1 mutation OR  

  2. eGFR loss > 3 ml/min/year (determined by ≥ 4 creatinine values within 4 years, ≥ 6 months measurement intervals) OR  

  3. PROPKD score > 6 (patient history) 

  • IF the patient is taking 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, necrotising fasciitis or organ transplantation 

  • Type 1 diabetes mellitus or any type of diabetes mellitus due to insulin deficiency 

  • Uncontrolled, active urinary tract or genital infections 

  • Known intolerance to ingredients of the study medication 

  • Uncontrolled grade 2 hypertension (>160/100 mmHg) 

  • Symptomatic hypotension or systolic blood pressure <90 mmHg 

  • Primary kidney 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 the time of enrolment) 

  • Pregnancy, breastfeeding or women of childbearing potential not using an effective method of contraception (see 9.2.1) 

  • Unable to comply with the study protocol in the investigator's judgement. 

  • Unable to provide informed consent 

  • Participation in another interventional clinical trial within the last 2 months