Autosomal dominant polycystic kidney disease polycystic kidney disease
Conditions
Interventions
After screening, subjects enter a first run-in period in which compliance to
the recommended diet is assessed. When subjects comply to the salt- and protein
recommendations, they enter a second run-
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of ADPKD, based upon modified Ravine criteria, or documented by their nephrologist or internist. 2. Prescribed tolvaptan as part of routine clinical care in the highest dose tolerable (preferably 120 mg daily) 3. Age >= 18 years. 4. eGFR >30 ml/min/1.73m2. 5. Providing informed consent. 6. Compliance to the recommended diet (
Exclusion criteria
Exclusion criteria: 1. Patients who, in the opinion of the investigator may present a safety risk. 2. Patients who are unlikely to adequately comply to the trial*s procedures (due for instance to medical conditions likely to require interruption or discontinuation, history of substance abuse or non-compliance). 3. a. Patients taking medication likely to confound endpoint assessments (lithium, systemic corticosteroids, diuretics). 3. b. Patients having concomitant illnesses likely to confound endpoint assessments (e.g. diabetes mellitus for which medication is needed or diabetes insipidus). 4. Women who are pregnant or breastfeeding. 5. Patients with limited access to water. 6. Patients with an abnormal sense of thirst.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable will be change in 24-hour urine volume as a percentage, comparing with the mean of the two 24-hour urine volumes collected at baseline versus the mean of the two volumes collected at the end of the two-week treatment periods with low salt, low protein and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes of this study will be changes in serum copeptin levels (the stable precursor of vasopressin), changes in mGFR (iohexol clearance), changes in blood pressure and quality of life using a questionnaire. Adverse events will be monitored, serum electrolytes will be checked. | — |
Countries
Netherlands
Outcome results
None listed