Research Project

Project Title:

FLUCOLITH:Fluconazole in Hypercalciuric Patients With Increased 1,25(OH)2D Levels

Project Type:

Clinical Trial, Enrolment not yet started
Adjunct biobank: Serum, Urine

Disease group(s):

Metabolic & stone disorders

Project Summary:

Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis leading to Chronic Kidney Disease and bone complications in adults.Hypercalciuria can be secondary to increased intestinal absorption and/or increased renal distal tubular reabsorption of calcium due to increased active vitamin D, i.e. 1,25(OH)2D, levels. The management of hypercalciuria is challenging. Classic management based on hyperhydration and dietary advice has low impact on calciuria and therefore on CKD progression. Other strategies such as hydrochlorothiazide can be proposed, however with an uncertain medical benefit in view of side effects. Azoles are known to inhibit1α-hydroxylase and therefore decrease 1,25(OH)2D levels. These antifungal drugs are commonly used in neonates, infants and adults; pharmacokinetic data are well described. Recently, to improve azoles tolerance, fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 mutation or NPTIIc mutations, while maintaining a stable renal function. Based on these observations, the investigators hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels.

Lead principal investigator(s):

Aurelia Bertholet-Thomas, Lyon

Co-investigator(s):

Justine Bacchetta, Lyon

Project Period:

12/2020   -   01/2023

Sponsors:

National funding agency

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