Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome
ConditionNephrotic Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMario Negri Institute for Pharmacological Research
About this trial
This retrospective study is aimed at evaluating the levels of circulating anti-nephrin autoantibodies in patients with INS, including those with MCD/FSGS and in patients who have experienced relapse of FSGS post-transplant, compared to those of a control group of patients with nephrotic syndrome due to primary membranous nephropathy (MN).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (>18 years) males and females
Patients with biopsy-proven idiopathic MCD or FSGS (cases)
Patients with biopsy-proven idiopathic membranous nephropathy (controls)
Patients who provided consent to store their samples in the certified CRB biobank
Disqualifiers
Reasonable possibility of a secondary cause of NS (for cases) or MN (for controls) at time of blood collections
Active viral or bacterial infections at time of blood collections
Trial population
For the measurement of anti-nephrin antibodies, serum samples stored at the certified Biobank of Rare Diseases and Kidney Diseases of the Mario Negri Pharmacological Research Institute IRCCS from patients with INS (MCD/FSGS) and MN who provided their consent to the conservation of biological samples for future research projects evaluated and authorized by an independent Ethics Committee will be selected.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa).
Diagnostic test"Nunc MaxiSorp" ELISA plates will be coated with recombinant extracellular domain of human nephrin. Patient serum samples will be added in appropriate dilution. Plates will be then incubated with biotin-conjugated anti human IgG antibody followed by incubation with horseradish peroxidase (HRP)-avidin conjugate. Then tetramethylbenzidine substrate will be added, and absorbance read at 450 nm.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Cases1 intervention
Group B: Controls1 intervention
Trial outcomes
Primary outcomes
1
Levels of circulating anti-nephrin autoantibodies
Serum samples will be tested for the levels of anti-nephrin autoantibodies by in-house ELISA and results confirmed by commercial ELISA kits.
Time frame
At 1 year. Given the retrospective nature of the study, the indicated time frame refers to the time required to perform the analysis, i.e to assess levels of anti-nephrin antibodies in patients with NS compared to controls.Sponsors and contacts
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Source ClinicalTrials.gov