Trial of prescribed water intake in polycystic kidney disease

Not Applicable

Completed

• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD); Renal and Urogenital - Kidney disease; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12614001216606
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-19
• Study Completion: 2021-06-30
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annualized rate of change (slope) in Ht-TKV (total kidney volume of both kidneys corrected for height) from baseline to Month 18 and Month 36 timepoints normalized as a percentage,[From Baseline to month 36]