Valproic Acid for Idiopathic Nephrotic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02896270
• Date of registration: 06/09/2016
• Prospective Registration: Yes
• Primary sponsor: Universitair Ziekenhuis Brussel
• Public title: Valproic Acid for Idiopathic Nephrotic Syndrome VAIN
• Scientific title: A Prospective Interventional Pilot Study on the Use of Valproic Acid for Treatment of Idiopathic Nephrotic Syndrome
• Date of first enrolment: October 2016
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02896270
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Belgium

Contacts

• Name: Peter Janssens, MD
• Affiliation: University Hospital Brussels, Belgium

• Name: Peter Janssens, MD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis

Idiopathic Nephrotic Syndrome

Minimal Change Disease

Intervention(s)

Drug: Valproic Acid

Primary Outcome(s)

In remission group induction is the proportion of patients in complete remission [Time Frame: 6 months]

In remission maintenance group is the proportion of patients able to reduce maintenance [Time Frame: 6 months]

Secondary Outcome(s)

Determine the extent to which standard immunosuppression can be reduced [Time Frame: 6 - 12 months]

Evaluate the evolution of renal function estimated by MDRD-GFR [Time Frame: 12 months]

Determine the disease response by the proportion of subjects with partial remission [Time Frame: 6 - 12 months]

Evaluate the tolerability of VPA in the setting of idiopathic podocytopathies [Time Frame: 12 months]

Secondary ID(s)

UZB_20160728

Source(s) of Monetary Support

Please refer to primary and secondary sponsors