Status:
UNKNOWN
Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt
Lead Sponsor:
Esther Meijer
Conditions:
Polycystic Kidney, Autosomal Dominant
ADPKD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates the effect of regulating salt and protein intake on urinevolume in patients with ADPKD treated with a vasopressine V2 receptor antagonist (V2RA). The investigators hypothesize tha...
Detailed Description
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is characterized by the formation of numerous cysts in both kidneys and progressive renal function decline leading to renal replacement therapy (RR...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04310319
Start Date
September 7 2020
End Date
October 1 2021
Last Update
November 5 2020
Active Locations (1)
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1
UMC Groningen
Groningen, Netherlands, 9713GZ