Status:
COMPLETED
Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Nephrolithiasis
Nephrocalcinosis
Eligibility:
All Genders
10-60 years
Phase:
PHASE2
Brief Summary
Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis leading to Chronic Kidney Disease (CKD) and bone complications in adults. Hyperc...
Eligibility Criteria
Inclusion
- Patients who presented in their medical history nephrolithiasis and/or nephrocalcinosis
- Patients who have at inclusion (V1), a local biological evaluation with:
- 24-hour urine calcium \> 0.1 mmol/kg/day,
- and 1,25(OH)2D levels ≥ 150 pmol/L,
- and 25-OH-D levels ≥ 20 nmol/L,
- and calcemia levels ≤ 2.65 mmol/L.
- Children from 10 years
- Adults until 60 years
- Women of child-bearing potential (including sexually active adolescent females) must use highly effective methods of contraception (Annex 7 CTFG recommendations) during the study period. Likewise, partners of male patients of child-bearing potential must use highly effective methods of contraception. Male patients must use condoms.
- Patients insured or beneficiary of a health insurance plan
- Evidence of signed and dated informed consent document(s) indicating that the subject and/or his parents/legal guardian has/have been informed of all pertinent aspects of the trial.
Exclusion
- Patient who already received fluconazole or ketoconazole during the last 6 months before inclusion
- Patient weight below than 28 kg
- Patient with BMI \>35
- Women menopaused
- Patients who cannot stop hydrochlorothiazide or other diuretics during the screening and study period
- Patients who cannot stop vitamin D supplementation and/or calcium supplementation (drugs, enriched waters, etc.) during the study period
- Hypersensibility to fluconazole and/or other derivative azoles and/or excipients
- Due to the presence of lactose excipient, patients presenting rare hereditary abnormalities of galactose intolerance, of Lapp lactase deficit or of glucose-galactose malabsorption
- Patients who need co-administration with other drugs known to prolong the QT interval and metabolized by cytochrome P450 (CYP) 3A4 (pimozide, quinidine and erythromycin; the exhaustive list of drugs known to prolong the QTc is available on: https://crediblemeds.org).
- Patients with iatrogenic hypercalciuria (vitamin D intoxication, immobilization)
- Relating to the risk of QT interval prolongation:
- congenital Long QT syndrome;
- familial history of sudden cardiac death before 50 years of age;
- cardiopathy: ischemia or myocardial infarction, congestive cardiac insufficiency, left ventricle hypertrophy, cardiomyopathy, conduction trouble within 6 months preceding the inclusion;
- arrhythmia history (in particular ventricular arrhythmia, auricular fibrillation or recent rhythm recovery after an auricular fibrillation);
- electrolytic instabilities: hypokalemia, hypomagnesemia, hypocalcemia ;
- bradycardia (\< 50 beats per minute) ;
- acute neurological events (i.e. intracranial hemorrhage or sub-arachnoid, cerebrovascular accident, intracranial trauma) within 6 months preceding the inclusion;
- adult patients with a QT interval/corrected QT interval \> 470ms for women and \> 450ms for men at the ECG performed at the inclusion visit (V1). For children from 10 years, the QT interval/corrected QT interval should be \> 460ms for girls and \> 450ms for boys.
- Children with a history of cardiac pathology
- Patients with an estimated glomerular filtration rate \< 60 mL/min/1.73m²
- Patients with a liver disease or an abnormality in the initial liver lab test
- Patients with enuresis
- Patients with another cause of identified lithiasis
- Patients suffering from granulomatosis pathology such as sarcoidosis
- Patient with hyperparathyroidism
- Women who are pregnant or breast feeding, or who have a project of pregnancy before the end of the study
- Patients with a project of travelling in a sunny area during the study period
- Immunodeficient patients
- Patients with other diseases or disorders that could preclude assessment
- Patient who is participating in another research study that may interfere with the results or conclusions of this study
- Patients under judicial protection.
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04495608
Start Date
January 13 2021
End Date
July 1 2024
Last Update
July 12 2024
Active Locations (11)
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1
Service de Néphrologie Rhumatologie Dermatologie Pédiatrique
Bron, France, Bron
2
CHU de Dijon
Dijon, France
3
Hôpital Edouard Herriot
Lyon, France
4
APHM - CHU Conception
Marseille, France