UnknownPhase 2/3

Valproic Acid for Idiopathic Nephrotic Syndrome

Belgium15 participantsStarted 2016-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

In remission group induction is the proportion of patients in complete remission

Timeframe: 6 months

In remission maintenance group is the proportion of patients able to reduce maintenance

Timeframe: 6 months

Trial details

NCT IDNCT02896270

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10

Contact for this trial

Peter Janssens, MD

+32 2 477 6224 peter.janssens@uzbrussel.be

View on ClinicalTrials.gov More Idiopathic Nephrotic Syndrome trials