NCT04310319

Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Esther Meijer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 that changing sodium and protein intake will reduce V2RA-induced polyuria.

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 (RRT) at a median age of 58 years. The first (and at the moment only) drug to slow down renal function decline, is a vasopressin V2 receptor antagonist (V2RA). This medicament slows renal function decline by 26 to 34%. V2RA also causes aquaresis associated side-effects such as polyuria of \>6 liter per day in the majority of patients. These side-effects limit wide spread use among ADPKD-patients. Therefore, there is a need to improve its tolerability. While using a V2RA, urine concentrating ability is strongly diminished. Therefore, urine volume is largely determined by total osmolar excretion. This is a well-known fact in nephrogenic diabetes insipidus, a disease with clear pathophysiological similarities to treatment with a vasopressin V2 receptor antagonist (a defect receptor versus pharmacological blockade). A recent study found osmolar excretion to be associated with urinary volume during V2RA treatment. Whether a change in osmolar load changes polyuria during V2RA has not yet been investigated. The investigators hypothesize that changing sodium and protein intake will reduce polyuria.

Conditions

• Polycystic Kidney, Autosomal Dominant
• ADPKD
• Autosomal Dominant Polycystic Kidney

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sodiumchloride	Subjects will receive 4 capsules containting 750 NaCl each 2dd, making a total of 6 grams NaCl per day.
DIETARY_SUPPLEMENT	Protein	Subjects will receive 2dd 40 ml of a protein beverage containing 0.5 grams of protein per ml, making a total of 40 grams of protein per day.
DIETARY_SUPPLEMENT	Placebo comparator (salt)	Subjects will receive 4 placebo capsules (identical to salt capsules) 2dd.
DIETARY_SUPPLEMENT	Placebo comparator (protein)	Subjects will receive 2dd 40 ml of placebo beverage (identical to protein beverage).

Timeline

• Start date: 2020-09-07
• Primary completion: 2021-09-01
• Completion: 2021-10-01
• First posted: 2020-03-17
• Last updated: 2020-11-05

Locations

1 site across 1 country: Netherlands