Valproic Acid for Idiopathic Nephrotic Syndrome

NCT02896270 | Unknown Phase 2 DMC

• 1 other identifier: UZB_20160728
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Idiopathic Nephrotic Syndrome; Focal Segmental Glomerulosclerosis; Minimal Change Disease

Keywords

idiopathic podocytopathies; Neprology

Outcome Measures

Primary Outcomes (2)

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

  Complete remission is defined as a reduction of proteinuria to \<300mg/g creatinine or \< 0.3g/d and normal serum creatinine (or stable creatinine if baseline creatinine before disease onset is well documented) and serum albumin \> 3.5g/dL.

  6 months

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

  The proportion of patients able to reduce maintenance immunosuppression to a monotherapy of 4 mg methylprednisolone or less while remaining in complete remission

  6 months

Secondary Outcomes (4)

• Determine the disease response by the proportion of subjects with partial remission

  6 - 12 months

• Determine the extent to which standard immunosuppression can be reduced

  6 - 12 months

• Evaluate the evolution of renal function estimated by MDRD-GFR

  12 months

• Evaluate the tolerability of VPA in the setting of idiopathic podocytopathies

  12 months

Study Arms (1)

single arm

EXPERIMENTAL

Patients will start study treatment on Day1 and will be treated with a dose of 250mg twice daily of the valproic acid slow release formulation (Depakine Chrono© - Sanofi Pharma Belgium). Control of valproic acid serum levels after 4 to 7 days. The dose will be progressively increased targeting valproic acid serum levels in the target range for use of the drug as an anti-epileptic (50-100µg/ml). During the study, visits will be performed every month and at the end of treatment. The duration of the study is 12 months. Continuation of valproic acid after completion of the study will be at the investigators discretion.

Drug: Valproic Acid

Interventions

Valproic Acid DRUG

The concomitant immunosuppressive regimen is to be reduced at the discretion of the investigators. It is suggested to lower immunosuppressive therapy only in valproic acid target trough levels have been attained.

Also known as: Depakine Chrono 500©, Sanofi

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (2)

University Hospital Brussels

Brussels, 1090, Belgium

RECRUITING

UVC Brugmann

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Nephrosis, Lipoid; Glomerulosclerosis, Focal Segmental

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Peter Janssens, MD

  University Hospital Brussels, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Janssens, MD

CONTACT

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

Nathalie Marmitte, Coordinator

CONTACT

+32 2 477 6224; nathalie.marmitte@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 12, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

BE (2)