Valproic Acid for Idiopathic Nephrotic Syndrome (VAIN)
Idiopathic Nephrotic Syndrome, Focal Segmental Glomerulosclerosis, Minimal Change Disease
About this trial
This is an interventional treatment trial for Idiopathic Nephrotic Syndrome focused on measuring idiopathic podocytopathies, Neprology
Eligibility Criteria
Inclusion Criteria:
- Able to give informed consent
- Biopsy proven idiopathic FSGS or MCD
Organ function:
- Bilirubin/AST/ALT< 2 ULN
- PLT>100.000 10*6/L
- INR 1.5 except if on anti-vitamin K treatment
- Lipase <1.5 ULN
- Creatinine clearance >30ml/min -
Exclusion Criteria:
- Contraindication for VPA
- Secondary etiologies for FSGS or MCD
- Multiple organ transplantation
- Currently participating in another clinical trial
- Pregnant or lactating women
- Women unwilling to take efficient contraceptive measures for the duration of the study
Sites / Locations
- University Hospital BrusselsRecruiting
- UVC BrugmannRecruiting
Arms of the Study
Arm 1
Experimental
single arm
Patients will start study treatment on Day1 and will be treated with a dose of 250mg twice daily of the valproic acid slow release formulation (Depakine Chrono© - Sanofi Pharma Belgium). Control of valproic acid serum levels after 4 to 7 days. The dose will be progressively increased targeting valproic acid serum levels in the target range for use of the drug as an anti-epileptic (50-100µg/ml). During the study, visits will be performed every month and at the end of treatment. The duration of the study is 12 months. Continuation of valproic acid after completion of the study will be at the investigators discretion.