Table 1.
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.