Valproic Acid for Idiopathic Nephrotic Syndrome

Phase 1

• Conditions: Treatment of Idiopathic Nephrotic Syndrome; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2016-003198-17-BE
• Lead Sponsor: niversitair Ziekenhuis Brussel Vrije Universiteit Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-07
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

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/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

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified