Randomised controlled trial to determine the efficacy and safety of prescribed water intake to prevent kidney failure due to Autosomal Dominant Polycystic Kidney Disease (PREVENT-ADPKD)

Western Sydney Local Health District0 个研究点目标入组 187 人开始时间: 2014年11月19日最近更新: 2021年11月22日

适应症

试验速览

暂无简介。

•1. Adult patients (18-67 years of age) providing informed consent
•2. Adult patients with a diagnosis of ADPKD
•3. eGFR of 30 mL/min/1.73m2 within 12 weeks of randomisation as determined by the chronic kidney disease epidemiology collaboration (CKD EPI) formula

•1. Patients who in the opinion of the trial investigators present a safety risk (including serum Na+ <135 mmol/L at screening; requirement for concomitant medications with a high risk of precipitating hyponatraemia, such as chronic use of diuretics; concomitant 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 breast-feeding women).
•2. Contraindication to or interference with MRI assessments (e.g. ferro-magnetic prostheses, aneurysm clips, severe claustrophobia or other contraindications)
•3. Patients who are unlikely to adequately comply with trial’s procedures (such as history of non-compliance with anti-hypertensive or other important medical therapy; history of substance abuse within the previous 2 years)
•4. Patients having concomitant illnesses or treatments likely to confound endpoint assessments (such as advanced and poorly controlled diabetes; evidence of significant renal disease not due to ADPKD, such as active glomerulonephritis, renal cancer or single kidney; severe co-morbid illnesses)
•5. Patients participating in other clinical trials to slow ADPKD or CKD
•6. Patients with Baseline TKV in Mayo Clinic Imaging Classes 1A

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