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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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