None listed
Conditions
Brief summary
ADPKD is an inherited condition, characterized by the growth of hundreds of cysts (fluid-filled sacs) in the kidney. This results in an enlarged kidney and pain, high blood pressure and an increased risk of chronic kidney disease. Kidney failure usually develops in late adulthood in about half of affected people. There is currently no treatment that can cure ADPKD or stop cysts forming and growing in the kidneys. In the last few years, people with ADPKD have been advised to drink more water to suppress anti-diuretic hormone (ADH, or vasopressin). However, it is not clear if this approach is feasible in the long-term and without risk and/or if there is an ideal amount of water to drink that will benefit disease progression. The aim of this study is to determine the efficacy and safety of prescribed water intake in ADPKD. Eligible patients with ADPKD will be randomised (1:1) to either: Group A (control) to continue with their usual (ad libitum) water consumption (including standard treatment) or Group B (intervention) to adjust their daily water intake to reduce the urine osmolality to less than or equal to 270 mosmol/L for the next 36 months in addition to their standard treatment. The volume of prescribed water consumption will be calculated according to free water clearance based on baseline and progress measurements of 24 hour urine collection. All patients will be expected to have blood collections at 3, 6, 9, 12, 18, 24, 30 and 36 months. In Group B subjects, additional samples will be collected at Week 3 and 6 for safety check and also titration of the water prescription. After the Month 36 visit, Group B patients may return to their previous ad libitum water consumption habits.
Interventions
Group A- Standard treatment and ad libitum water consumption for 36 months. Standard treatment is defined as generic approaches (weight management, salt restriction, smoking cessation, blood pressure control) to slow the progression of chronic kidney disease; which include the standard care from the participants' usual physician.
Group B- Standard treatment and prescribed water consumption for 36 months. In Group B, the individualized daily water prescription to reduce the urine osmolality will
Group A- Standard treatment and ad libitum water consumption for 36 months. Standard treatment is defined as generic approaches (weight management, salt restriction, smoking cessation, blood pressure control) to slow the progression of chronic kidney disease; which include the standard care from the participants' usual physician. Group B- Standard treatment and prescribed water consumption for 36 months. In Group B, the individualized daily water prescription to reduce the urine osmolality will be calculated using the free water clearance formula. The study dietitian provided personalized counseling for consuming the water prescription, considering lifestyle, dietary solute intake, and preferences. In addition, patients self-monitored urine specific gravity (USG) (daily for the first 2 weeks, twice weekly for the first 6 months, and then as needed) to keep it below 1.010. The water prescription was re-calculated during follow-up visits using 24-hour urine osmolality (3-monthly during in the first year and then 6-monthly in the second and third years). Patients in both groups underwent the same follow-up tests and visits.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 67 Years
Healthy volunteers
No
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
Outcome results
None listed