Valproic Acid for Idiopathic Nephrotic Syndrome

A Prospective Interventional Pilot Study on the Use of Valproic Acid for Treatment of Idiopathic Nephrotic Syndrome - VAIN study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003198-17-BE

Enrollment

Registered

2016-09-07

Start date

2016-09-29

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Idiopathic Nephrotic Syndrome

Interventions

Trade Name: Depakine Chrono 500© Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18 years and older Able to give informed consent Biopsy proven idiopathic FSGS or MCD For remission induction (currently induction therapy): • Proteinuria >1g/g creatinine • Subjects received high dose prednisone (1mg/kg-maximum 80mg prednisone-equivalent) according to guidelines or present relative contraindications or intoler-ance to high-dose corticosteroids during induction. For remission maintenance (currently in remission): • At least one relaps • Requiring reduction or cessation of current maintenance immunosuppressive therapy required to maintain remission. Organ function: • Bilirubin/AST/ALT100.000 10*6/L • INR?1.5 except if on anti-vitamin K treatment • Lipase 30ml/min Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Patients younger than 18 years Unable to give informed consent 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) VPA (Valproic acid) 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. This is an exploratory pilot study with two different sub-cohorts of patients which have different endpoints. ;Secondary Objective: Determine the disease response by the proportion of subjects with partial remission Determine the extent to which standard immunosuppression can be reduced Evaluate the evolution of renal function estimated by MDRD-GFR Evaluate the tolerability of VPA in the setting of idiopathic podocytopathies ;Primary end point(s): The primary endpoint in remission induction is the proportion of patients in complete remission. Complete remission is defined as a reduction of proteinuria to 3.5g/dL. The primary endpoint in remission maintenance is the proportion of patients able to reduce maintenance immunosuppression to a monotherapy of 4 mg methylprednisolone or less while remaining in complete remission as defined above. ;Timepoint(s) of evaluation of this end point: For both groups, 6 months after inclusion	—

Measure

Time frame

Main Objective: 1) VPA (Valproic acid) 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. This is an exploratory pilot study with two different sub-cohorts of patients which have different endpoints. ;Secondary Objective: Determine the disease response by the proportion of subjects with partial remission Determine the extent to which standard immunosuppression can be reduced Evaluate the evolution of renal function estimated by MDRD-GFR Evaluate the tolerability of VPA in the setting of idiopathic podocytopathies ;Primary end point(s): The primary endpoint in remission induction is the proportion of patients in complete remission. Complete remission is defined as a reduction of proteinuria to 3.5g/dL. The primary endpoint in remission maintenance is the proportion of patients able to reduce maintenance immunosuppression to a monotherapy of 4 mg methylprednisolone or less while remaining in complete remission as defined above. ;Timepoint(s) of evaluation of this end point: For both groups, 6 months after inclusion

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Secondary

Measure	Time frame
Secondary end point(s): Remission induction: 1) The proportion of subjects with partial remission defined as a reduction in proteinuria to 0.3-3.5g/d or 300-3500mg/g creatinine and a decrease of at least 50% from baseline proteinuria and stable serum creatinine (change in creatinine 3.5g/d or >3500mg/g) after minimization or cessation of immunosuppression on VPA. 4) Evolution of renal function estimated by CKD-EPI. ;Timepoint(s) of evaluation of this end point: Remission induction: 1) The proportion of subjects with partial remission at 6 months 2) The percent change in proteinuria at 6 months 3) The proportion of patients attaining full or partial remission with 4mg methylprednisolone or less at 6 months and 12 months 4) Evolution of renal function at 6 and 12 months Remission maintenance: 1) the proportion of patients remaining in remission for at least 6 months after reduction of maintenance immunosuppression 2) The percent reduction in the dosage of immunosuppression in patients who remain in remission at 6 and 12 months 3) The proportion of patients with relapse after minimization or cessation of immunosuppression on VPA at 6 and 12 months 4) Evolution of renal function at 6 and 12 months	—

Measure

Time frame

Secondary end point(s): Remission induction: 1) The proportion of subjects with partial remission defined as a reduction in proteinuria to 0.3-3.5g/d or 300-3500mg/g creatinine and a decrease of at least 50% from baseline proteinuria and stable serum creatinine (change in creatinine 3.5g/d or >3500mg/g) after minimization or cessation of immunosuppression on VPA. 4) Evolution of renal function estimated by CKD-EPI. ;Timepoint(s) of evaluation of this end point: Remission induction: 1) The proportion of subjects with partial remission at 6 months 2) The percent change in proteinuria at 6 months 3) The proportion of patients attaining full or partial remission with 4mg methylprednisolone or less at 6 months and 12 months 4) Evolution of renal function at 6 and 12 months Remission maintenance: 1) the proportion of patients remaining in remission for at least 6 months after reduction of maintenance immunosuppression 2) The percent reduction in the dosage of immunosuppression in patients who remain in remission at 6 and 12 months 3) The proportion of patients with relapse after minimization or cessation of immunosuppression on VPA at 6 and 12 months 4) Evolution of renal function at 6 and 12 months

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Countries

Belgium

Contacts

Public ContactDr. Peter Janssens

Universitair Ziekenhuis Brussel Vrije Universiteit Brussel

Peter.Janssens@uzbrussel.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026