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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02896270
Study type Interventional
Source Universitair Ziekenhuis Brussel
Contact Peter Janssens, MD
Phone +32 2 477 6224
Email peter.janssens@uzbrussel.be
Status Recruiting
Phase Phase 2/Phase 3
Start date October 2016
Completion date December 2019

See also
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Terminated NCT00883636 - Cardiomyopathy in Steroid-resistant Nephrotic Syndrome: Impact of Focal Segmental Glomerulosclerosis N/A
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Terminated NCT03703908 - A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome Phase 2
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Completed NCT00464321 - Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS Phase 1
Completed NCT03536754 - A Study of CCX140-B in Subjects With FSGS Phase 2
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