Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt (WATER)
Polycystic Kidney, Autosomal Dominant, ADPKD, Autosomal Dominant Polycystic Kidney
About this trial
This is an interventional treatment trial for Polycystic Kidney, Autosomal Dominant focused on measuring ADPKD, aquaresis, Vasopressine V2 receptor antagonist, Diet
Eligibility Criteria
Inclusion criteria:
- Diagnosis of ADPKD (ravine criteria/documented by nephrologist)
- Stable treatment regimen of tolvaptan as part of routine clinical care in the highest dose tolerable (preferably 120 mg daily), with a urine osmolality lower than 250 mosmol/L.
- Age >= 18 years.
- eGFR >30 ml/min/1.73m2.
- Providing informed consent.
- Compliance to the recommended diet at two consecutive times.
Exclusion criteria:
- Patients who, in the opinion of the investigator may present a safety risk.
- 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).
a. Patients taking medication likely to confound endpoint assessments:
- lithium in any dosing regimen;
- chronic use of systemic corticosteroids in any dosage;
- chronic use of any diuretics in any dosing regimen;
- daily use of any NSAIDs in any dosing regimen;
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 a blood pressure over 160/100 mm Hg at baseline.
Sites / Locations
- UMC GroningenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
Normal salt, low protein treatment period
Normal salt, normal protein treatment period
Low salt, low protein treatment period
Low salt, normal protein treatment period
6 grams of sodium chloride daily / Placebo
6 grams of sodium chloride daily / 40 grams of protein daily
Double placebo
Placebo / 40 grams of protein daily