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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02896270 |
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Date of registration:
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06/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Valproic Acid for Idiopathic Nephrotic Syndrome
VAIN |
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Scientific title:
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A Prospective Interventional Pilot Study on the Use of Valproic Acid for Treatment of Idiopathic Nephrotic Syndrome |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02896270 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Peter Janssens, MD |
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Address:
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Telephone:
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+32 2 477 6224 |
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Email:
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peter.janssens@uzbrussel.be |
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Affiliation:
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Name:
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Peter Janssens, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Brussels, Belgium |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Focal Segmental Glomerulosclerosis
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Idiopathic Nephrotic Syndrome
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Minimal Change Disease
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Intervention(s)
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Drug: Valproic Acid
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Primary Outcome(s)
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In remission group induction is the proportion of patients in complete remission
[Time Frame: 6 months]
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In remission maintenance group is the proportion of patients able to reduce maintenance
[Time Frame: 6 months]
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Secondary Outcome(s)
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Determine the extent to which standard immunosuppression can be reduced
[Time Frame: 6 - 12 months]
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Evaluate the evolution of renal function estimated by MDRD-GFR
[Time Frame: 12 months]
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Determine the disease response by the proportion of subjects with partial remission
[Time Frame: 6 - 12 months]
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Evaluate the tolerability of VPA in the setting of idiopathic podocytopathies
[Time Frame: 12 months]
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Secondary ID(s)
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UZB_20160728
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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