Table 1

Inclusion and exclusion criteria

Inclusion criteria
1.Adult patients providing informed consent, aged 18–65 years of age
2.Diagnosis of ADPKD, such as meeting the Pei-Ravine criteria52
3.eGFR (CKD-EPI) ≥30 mL/min/1.73 m2 within 6 weeks of randomisation
Exclusion criteria
1.Safety risk, eg, serum Na+ <135 mmol/L; requirement for medications with high risk of precipitating hyponatraemia, such as chronic use of diuretics; medical conditions that require fluid restriction, such as heart failure, chronic liver disease, nephrotic syndrome or generalised oedema; abnormalities in the voiding mechanism; pregnant or breastfeeding women
2.Contraindication to or interference with MRI assessments (eg, ferromagnetic prostheses, aneurysm clips, severe claustrophobia or other contraindications)
3.Risk of non-compliance with trial procedures (eg, history of non-compliance with medical therapy; history of substance abuse within the previous 2 years and/or participants who do not complete the required screening tests (24 hours urine, blood tests and baseline MRI) within 12 weeks of the screening visit)
4.Concomitant conditions or treatments likely to confound end point assessments (eg, poorly controlled diabetes, other known causes of CKD, renal cancer, single kidney or severe comorbid illnesses)
5.Participation in other clinical trials to slow ADPKD or CKD
6.TKV Mayo Clinic subclass 1A on screening (low risk of progression)53
  • ADPKD, autosomal dominant polycystic kidney disease; CKD, chronic kidney disease; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration equation; eGFR, estimated glomerular filtration rate; TKV, total kidney volume.