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A Prospective Interventional Pilot Study on the Use of Valproic Acid for Treatment of Idiopathic Nephrotic Syndrome (NCT02896270)

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.
  • Drug: Valproic Acid
    The concomitant immunosuppressive regimen is to be reduced at the discretion of the investigators. It is suggested to lower immunosuppressive therapy only in valproic acid target trough levels have been attained.
    • Depakine Chrono 500©, Sanofi
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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
Idiopathic MCD to treat diseases with a considerable associated morbidity and mortality. Current treatment options are limited, have limited efficacy and a considerable side effect profile. Recent findings in a murine model suggest that VPA treatment in an early phase of renal disease could halt or even prevent the development of proteinuria and the progression of kidney damage. VPA is a commonly used and easy available oral antiepileptic agent with a favorable side effect profile compared to the current standard of care agents for podocytopathies.

This trial investigates wether

1. VPA on top of or in substitution of standard of care agents is effective in remission induction in patients with FSGS or MCD with proteinuria resistant to first line therapy with corticosteroids.

2. VPA is effective in remission maintenance allowing reduction and cessation of chronic immunosuppression without relapse in patients with frequently relapsing FSGS or MCD.

2 locations

Belgium (2)
  • University Hospital Brussels
    recruiting
    Brussels, Belgium, 1090
  • UVC Brugmann
    recruiting
    Brussels, Belgium
Status:
recruiting
Type:
Interventional
Phase:
Ⅱ, Ⅲ
Start:
30 September, 2016
Updated:
15 June, 2017
Participants:
15
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