Nephrotic SyndromeBLINDERNCT06334692
Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome
An observational study of Nephrotic Syndrome, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa).
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 19 Mar 2024to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinical Research Center for Rare Disease Aldo e Cele Daccò
Ranica, BG, 24020
Federica Casiraghi, PhD, +3903545351, federica.casiraghi@marionegri.it
About this study
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).
Read the detailed description
Nephrotic syndrome (NS) is one of the major "unsolved problems" in nephrology and represents a long-standing challenge in terms of pathogenetic mechanisms and the search for an effective cure.
Nephrotic-range proteinuria (>3.5 g/day) is accompanied by a set of abnormalities collectively known as NS. It is characterized by systemic complications resulting from alterations in the composition of the body's protein pool, sodium retention, dyslipidemia, coagulation factor abnormalities and a variable degree of renal failure. When secondary causes cannot be identified, the clinical presentation is called idiopathic nephrotic syndrome (INS). INS is associated with disappearance of podocyte pedicels (visible under the electron microscope) and minimal changes (minimal change disease, MCD) or, at the more advanced stage, focal segmental glomerulosclerosis (FSGS) under the light microscope. INS can be treated with corticosteroids, which represent the first-line treatment, however, among the forms of NS, FSGS has the lowest rate of response to therapy. More importantly, in 30% of patients with FSGS, disease recurrence develops rapidly after transplantation, sometimes within minutes or hours, and leads to the immediate onset of proteinuria and graft dysfunction. For post-transplant FSGS recurrence, no prevention or treatment strategies are available and current therapeutic approaches are mostly based on clinical experience.
The recurrence of FSGS in the transplanted kidney presupposes the presence of one or more circulating factors of extrarenal origin which can selectively affect and damage the glomerular barrier, in particular the podocytes, resulting in massive proteinuria. However, the identity, nature and cellular source of factors circulating in the INS are not yet known.
Recent evidence of the therapeutic efficacy of anti-B cell antibodies in inducing and/or maintaining remission in patients with INS indicates the presence of possible B cell dysfunction.
In support of this, a recent study described the presence of anti-nephrin autoantibodies (a structural component of the podocyte slit diaphragm) in a subgroup of pediatric and adult patients with MCD. These autoantibodies were present during the active phase of the disease, and were associated with a punctate staining of IgG in renal biopsies in correspondence with the specific areas of presence of nephrin. Furthermore, the presence of autoantibodies against nephrin has been found in early post-transplant FSGS recurrence. This preliminary result was confirmed by a Japanese multicenter study conducted on 11 pediatric patients with post-transplant FSGS recurrence. In these patients, anti-nephrin autoantibodies were elevated both before transplantation and during disease relapse and were related to punctate deposition of immunoglobulins G (IgG) that colocalized with nephrin in the graft biopsy at the time of relapse. This recent evidence suggests that circulating anti-nephrin antibodies represent a possible circulating factor involved in the pathogenesis of INS, in particular post-transplant FSGS recurrence.
- Conditions
- Nephrotic Syndrome
- Being tested
- In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa).
- Keywords
- Idiopathic nephrotic syndrome, Minimal change disease, Focal segmental glomerulosclerosis, Permeability factor(s), B cells, Nephrin autoantibodies
- Medical subject headings
- Nephrotic Syndrome, Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Sera from patients with biopsy-proven idiopathic MCD or FSGS who provided consent to store their samples in the certified biobank (Mario Negri Biological Resources Centre - Rare Diseases and Renal Diseases Biobank - CRB). Serum samples will be tested for the levels of anti-nephrin autoantibodies by in-house ELISA and results confirmed by commercial ELISA kits. Receives: Diagnostic Test: In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa). | |
| Controls | Sera from patients with biopsy-proven idiopathic membranous nephropathy who provided consent to store their samples in the certified biobank (Mario Negri Biological Resources Centre - Rare Diseases and Renal Diseases Biobank - CRB). Samples will be tested for the levels of anti-nephrin autoantibodies by in-house ELISA and results confirmed by commercial ELISA kits. Receives: Diagnostic Test: In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start19 Mar 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Remuzzi, MD, Study director, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334692
- Sponsor's protocol ID
- BLINDER
- Acronym
- BLINDER
- Status last verified
- May 2025
- First submitted
- 15 Mar 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCarthy ET, Sharma M, Savin VJ. Circulating permeability factors in idiopathic nephrotic syndrome and focal segmental glomerulosclerosis. Clin J Am Soc Nephrol. 2010 Nov;5(11):2115-21. doi: 10.2215/CJN.03800609. Epub 2010 Oct 21.
PubMed 20966123D'Agati VD, Kaskel FJ, Falk RJ. Focal segmental glomerulosclerosis. N Engl J Med. 2011 Dec 22;365(25):2398-411. doi: 10.1056/NEJMra1106556. No abstract available.
PubMed 22187987Gallon L, Leventhal J, Skaro A, Kanwar Y, Alvarado A. Resolution of recurrent focal segmental glomerulosclerosis after retransplantation. N Engl J Med. 2012 Apr 26;366(17):1648-9. doi: 10.1056/NEJMc1202500. No abstract available.
PubMed 22533598Ruggenenti P, Ruggiero B, Cravedi P, Vivarelli M, Massella L, Marasa M, Chianca A, Rubis N, Ene-Iordache B, Rudnicki M, Pollastro RM, Capasso G, Pisani A, Pennesi M, Emma F, Remuzzi G; Rituximab in Nephrotic Syndrome of Steroid-Dependent or Frequently Relapsing Minimal Change Disease Or Focal Segmental Glomerulosclerosis (NEMO) Study Group. Rituximab in steroid-dependent or frequently relapsing idiopathic nephrotic syndrome. J Am Soc Nephrol. 2014 Apr;25(4):850-63. doi: 10.1681/ASN.2013030251. Epub 2014 Jan 30.
PubMed 24480824Maas RJ, Deegens JK, Smeets B, Moeller MJ, Wetzels JF. Minimal change disease and idiopathic FSGS: manifestations of the same disease. Nat Rev Nephrol. 2016 Dec;12(12):768-776. doi: 10.1038/nrneph.2016.147. Epub 2016 Oct 17.
PubMed 27748392Watts AJB, Keller KH, Lerner G, Rosales I, Collins AB, Sekulic M, Waikar SS, Chandraker A, Riella LV, Alexander MP, Troost JP, Chen J, Fermin D, Yee JL, Sampson MG, Beck LH Jr, Henderson JM, Greka A, Rennke HG, Weins A. Discovery of Autoantibodies Targeting Nephrin in Minimal Change Disease Supports a Novel Autoimmune Etiology. J Am Soc Nephrol. 2022 Jan;33(1):238-252. doi: 10.1681/ASN.2021060794. Epub 2021 Nov 3.
PubMed 34732507Casiraghi F, Todeschini M, Podesta MA, Mister M, Ruggiero B, Trillini M, Carrara C, Diadei O, Villa A, Benigni A, Remuzzi G. Immunophenotypic Alterations in Adult Patients with Steroid-Dependent and Frequently Relapsing Nephrotic Syndrome. Int J Mol Sci. 2023 Apr 22;24(9):7687. doi: 10.3390/ijms24097687.
PubMed 37175393Salfi G, Casiraghi F, Remuzzi G. Current understanding of the molecular mechanisms of circulating permeability factor in focal segmental glomerulosclerosis. Front Immunol. 2023 Sep 19;14:1247606. doi: 10.3389/fimmu.2023.1247606. eCollection 2023.
PubMed 37795085Shirai Y, Miura K, Ishizuka K, Ando T, Kanda S, Hashimoto J, Hamasaki Y, Hotta K, Ito N, Honda K, Tanabe K, Takano T, Hattori M. A multi-institutional study found a possible role of anti-nephrin antibodies in post-transplant focal segmental glomerulosclerosis recurrence. Kidney Int. 2024 Mar;105(3):608-617. doi: 10.1016/j.kint.2023.11.022. Epub 2023 Dec 16.
PubMed 38110152Pecoraro F, Perico L, Casiraghi F, Rizzo P, Trillini M, Angeletti A, Podesta MA, Kajana X, Spennacchio A, Todeschini M, Mister M, Castellano G, Benigni A, Remuzzi G. Anti-nephrin antibodies are not enriched in patients with primary and posttransplant recurrent podocytopathies. J Clin Invest. 2026 Apr 28;136(13):e204727. doi: 10.1172/JCI204727. eCollection 2026 Jul 1.
PubMed 42048157
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT06334692
- Acronym / sponsor ID
- BLINDER / BLINDER
- Conditions
- Nephrotic Syndrome
- Keywords
- Idiopathic nephrotic syndrome, Minimal change disease, Focal segmental glomerulosclerosis, Permeability factor(s), B cells, Nephrin autoantibodies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Nephrotic syndrome (NS) is one of the major "unsolved problems" in nephrology and represents a long-standing challenge in terms of pathogenetic mechanisms and the search for an effective cure.
Nephrotic-range proteinuria (>3.5 g/day) is accompanied by a set of abnormalities collectively known as NS. It is characterized by systemic complications resulting from alterations in the composition of the body's protein pool, sodium retention, dyslipidemia, coagulation factor abnormalities and a variable degree of renal failure. When secondary causes cannot be identified, the clinical presentation is called idiopathic nephrotic syndrome (INS). INS is associated with disappearance of podocyte pedicels (visible under the electron microscope) and minimal changes (minimal change disease, MCD) or, at the more advanced stage, focal segmental glomerulosclerosis (FSGS) under the light microscope. INS can be treated with corticosteroids, which represent the first-line treatment, however, among the forms of NS, FSGS has the lowest rate of response to therapy. More importantly, in 30% of patients with FSGS, disease recurrence develops rapidly after transplantation, sometimes within minutes or hours, and leads to the immediate onset of proteinuria and graft dysfunction. For post-transplant FSGS recurrence, no prevention or treatment strategies are available and current therapeutic approaches are mostly based on clinical experience.
The recurrence of FSGS in the transplanted kidney presupposes the presence of one or more circulating factors of extrarenal origin which can selectively affect and damage the glomerular barrier, in particular the podocytes, resulting in massive proteinuria. However, the identity, nature and cellular source of factors circulating in the INS are not yet known.
Recent evidence of the therapeutic efficacy of anti-B cell antibodies in inducing and/or maintaining remission in patients with INS indicates the presence of possible B cell dysfunction.
In support of this, a recent study described the presence of anti-nephrin autoantibodies (a structural component of the podocyte slit diaphragm) in a subgroup of pediatric and adult patients with MCD. These autoantibodies were present during the active phase of the disease, and were associated with a punctate staining of IgG in renal biopsies in correspondence with the specific areas of presence of nephrin. Furthermore, the presence of autoantibodies against nephrin has been found in early post-transplant FSGS recurrence. This preliminary result was confirmed by a Japanese multicenter study conducted on 11 pediatric patients with post-transplant FSGS recurrence. In these patients, anti-nephrin autoantibodies were elevated both before transplantation and during disease relapse and were related to punctate deposition of immunoglobulins G (IgG) that colocalized with nephrin in the graft biopsy at the time of relapse. This recent evidence suggests that circulating anti-nephrin antibodies represent a possible circulating factor involved in the pathogenesis of INS, in particular post-transplant FSGS recurrence.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa).Sera from patients with biopsy-proven idiopathic MCD or FSGS who provided consent to store their samples in the certified biobank (Mario Negri Biological Resources Centre - Rare Diseases and Renal Diseases Biobank - CRB). Serum samples will be tested for the levels of anti-nephrin autoantibodies by in-house ELISA and results confirmed by commercial ELISA kits. |
| Controls | – | Diagnostic Test: In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa).Sera from patients with biopsy-proven idiopathic membranous nephropathy who provided consent to store their samples in the certified biobank (Mario Negri Biological Resources Centre - Rare Diseases and Renal Diseases Biobank - CRB). Samples will be tested for the levels of anti-nephrin autoantibodies by in-house ELISA and results confirmed by commercial ELISA kits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa)."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. | Diagnostic test | Cases, Controls |
Primary outcome
Levels of circulating anti-nephrin autoantibodies
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.
Serum samples will be tested for the levels of anti-nephrin autoantibodies by in-house ELISA and results confirmed by commercial ELISA kits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 20966123McCarthy ET, Sharma M, Savin VJ. Circulating permeability factors in idiopathic nephrotic syndrome and focal segmental glomerulosclerosis. Clin J Am Soc Nephrol. 2010 Nov;5(11):2115-21. doi: 10.2215/CJN.03800609. Epub 2010 Oct 21.
- Background: PubMed 22187987D'Agati VD, Kaskel FJ, Falk RJ. Focal segmental glomerulosclerosis. N Engl J Med. 2011 Dec 22;365(25):2398-411. doi: 10.1056/NEJMra1106556. No abstract available.
- Background: PubMed 22533598Gallon L, Leventhal J, Skaro A, Kanwar Y, Alvarado A. Resolution of recurrent focal segmental glomerulosclerosis after retransplantation. N Engl J Med. 2012 Apr 26;366(17):1648-9. doi: 10.1056/NEJMc1202500. No abstract available.
- Background: PubMed 24480824Ruggenenti P, Ruggiero B, Cravedi P, Vivarelli M, Massella L, Marasa M, Chianca A, Rubis N, Ene-Iordache B, Rudnicki M, Pollastro RM, Capasso G, Pisani A, Pennesi M, Emma F, Remuzzi G; Rituximab in Nephrotic Syndrome of Steroid-Dependent or Frequently Relapsing Minimal Change Disease Or Focal Segmental Glomerulosclerosis (NEMO) Study Group. Rituximab in steroid-dependent or frequently relapsing idiopathic nephrotic syndrome. J Am Soc Nephrol. 2014 Apr;25(4):850-63. doi: 10.1681/ASN.2013030251. Epub 2014 Jan 30.
- Background: PubMed 27748392Maas RJ, Deegens JK, Smeets B, Moeller MJ, Wetzels JF. Minimal change disease and idiopathic FSGS: manifestations of the same disease. Nat Rev Nephrol. 2016 Dec;12(12):768-776. doi: 10.1038/nrneph.2016.147. Epub 2016 Oct 17.
- Background: PubMed 34732507Watts AJB, Keller KH, Lerner G, Rosales I, Collins AB, Sekulic M, Waikar SS, Chandraker A, Riella LV, Alexander MP, Troost JP, Chen J, Fermin D, Yee JL, Sampson MG, Beck LH Jr, Henderson JM, Greka A, Rennke HG, Weins A. Discovery of Autoantibodies Targeting Nephrin in Minimal Change Disease Supports a Novel Autoimmune Etiology. J Am Soc Nephrol. 2022 Jan;33(1):238-252. doi: 10.1681/ASN.2021060794. Epub 2021 Nov 3.
- Background: PubMed 37175393Casiraghi F, Todeschini M, Podesta MA, Mister M, Ruggiero B, Trillini M, Carrara C, Diadei O, Villa A, Benigni A, Remuzzi G. Immunophenotypic Alterations in Adult Patients with Steroid-Dependent and Frequently Relapsing Nephrotic Syndrome. Int J Mol Sci. 2023 Apr 22;24(9):7687. doi: 10.3390/ijms24097687.
- Background: PubMed 37795085Salfi G, Casiraghi F, Remuzzi G. Current understanding of the molecular mechanisms of circulating permeability factor in focal segmental glomerulosclerosis. Front Immunol. 2023 Sep 19;14:1247606. doi: 10.3389/fimmu.2023.1247606. eCollection 2023.
- Background: PubMed 38110152Shirai Y, Miura K, Ishizuka K, Ando T, Kanda S, Hashimoto J, Hamasaki Y, Hotta K, Ito N, Honda K, Tanabe K, Takano T, Hattori M. A multi-institutional study found a possible role of anti-nephrin antibodies in post-transplant focal segmental glomerulosclerosis recurrence. Kidney Int. 2024 Mar;105(3):608-617. doi: 10.1016/j.kint.2023.11.022. Epub 2023 Dec 16.
- Derived from this study: PubMed 42048157Pecoraro F, Perico L, Casiraghi F, Rizzo P, Trillini M, Angeletti A, Podesta MA, Kajana X, Spennacchio A, Todeschini M, Mister M, Castellano G, Benigni A, Remuzzi G. Anti-nephrin antibodies are not enriched in patients with primary and posttransplant recurrent podocytopathies. J Clin Invest. 2026 Apr 28;136(13):e204727. doi: 10.1172/JCI204727. eCollection 2026 Jul 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe Remuzzi, MD study director
Istituto Di Ricerche Farmacologiche Mario Negri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federica Casiraghi, PhD (+3903545351, federica.casiraghi@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of circulating anti-nephrin autoantibodies (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334692, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.