Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

January 13, 2021

Primary Completion Date

July 1, 2024

Study Completion Date

July 1, 2024

Conditions
NephrolithiasisNephrocalcinosisHypercalciuria
Interventions
DRUG

Fluconazole

"Fluconazole 50 mg/capsule or placebo, per os during 18 weeks :~* From W0 to W2 : 1 caps/ day~* From W2 to W4 : 1 or 2 caps/day~* From W4 to W6 : 1, 2 or 3 caps/day~* From W6 to W18 : 1, 2, 3 or 4 caps/day~The number of capsules to take will be determined by 24-hours calciuria results performed every 2 weeks during the titration period (W2, W4 and W6).~During the titration period, if 24-hours calciuria is \> 0.1 mmol/kg/day, fluconazole dose will be increased every 2 weeks to 50 mg per intake, with a maximum dose of 200 mg/day. If 24-hour calciuria is ≤ 0.1mmol/kg/day, fluconazole dose will remain stable.~After W6 and until the end of the study, the treatment dose will remain stable (stable period)."

DRUG

Placebo

Placebo (1, 2, 3 or 4 pills to take daily during 18 weeks), same appearance to experimental drug

Trial Locations (11)

75743

Hôpital Universitaire Necker, Paris

Bron

Service de Néphrologie Rhumatologie Dermatologie Pédiatrique, Bron

Unknown

CHU de Dijon, Dijon

Hôpital Edouard Herriot, Lyon

APHM - CHU Conception, Marseille

CHR Metz-Thionville, Metz

CHU de Nantes, Nantes

APHP - Hôpital Européen Georges Pompidou HEGP, Paris

Hôpital Universitaire Necker-Enfants Malades, Paris

CHU Rennes Pontchaillou, Rennes

CHU de Strasbourg, hôpital de Hautepierre, Strasbourg

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT04495608 - Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels | Biotech Hunter | Biotech Hunter