NL-OMON50000CompletedNot Applicable
Wishing to decrease Aquaresis in ADPKD patients Treated with a V2Ra; the Effect of Regulating protein and salt - WATER
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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 (<9 grams of salt per day, < 1,2 grams of
- •protein per kg ideal bodyweight per day) at two consecutive times.
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.
Investigators
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