Focal Segmental Glomerulosclerosis Clinical Trial
Official title:
A Prospective Interventional Pilot Study on the Use of Valproic Acid for Treatment of Idiopathic Nephrotic Syndrome
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.
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.
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