Valproic Acid for Idiopathic Nephrotic Syndrome

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial investigates the use of VPA (Valproic Acid) for the treatment of adult patients with biopsy proven idiopathic focal segmentel glomerulosclerosis (FSGS) or minimal change disease (MCD).

VPA used as an add-on to steroids might induce clinical remission in a first category of patients and potentially reduce the dose of maintenance immunosuppression required to maintain remission thereafter.

In a second category of patients VPA might allow the reduction or even cessation of immunosuppression while clinical remission is maintained.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitair Ziekenhuis Brussel
• Treatments: Valproic Acid

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