Wishing to decrease Aquaresis in ADPKD patients Treated with a V2Ra; the Effect of Regulating protein and salt

Completed

• Conditions: 10038360; Autosomal dominant polycystic kidney disease; polycystic kidney disease; 10029149

• Registration Number: NL-OMON50000
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified