Nephrotic Syndrome With Edema (Diagnosis)NCT07516964
SLIT ABS: Study on Patients With Autoimmune Podocytopathy
A study testing Serum and renal tissue analysis in people with Nephrotic Syndrome With Edema (Diagnosis) and Minimal Change Nephrotic Syndrome, run by Meyer Children's Hospital IRCCS at 14 sites in 5 countries.
Trial summary
Nephrotic syndrome is a kidney condition that mainly affects children and is characterized by high levels of protein in the urine, low levels of protein in the blood, and swelling. While many children respond well to steroid treatment, a large proportion experience relapses or become dependent on therapy. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Nephrotic Syndrome With Edema (Diagnosis), Minimal Change Nephrotic Syndrome, Focal Segmental Glomerulosclerosis (FSGS)
- What is being tested?
- Serum and renal tissue analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 10 Jun 2025to Oct 2036
- Phase
- Interventional
- 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 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pediatric and adult patients with a diagnosis of podocytopathy
- Patients with nephrotic syndrome and/or histological diagnosis of minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), collapsing glomerulopathy (CG), or diffuse mesangial sclerosis (DMS)
- Both newly diagnosed (incident) patients and patients already under follow-up at participating centers
- Availability of clinical data from medical records (including paper and/or electronic records, laboratory reports, and discharge summaries)
- Availability of biological samples (e.g., blood and/or renal biopsy), if collected as part of routine clinical care
- Signed informed consent by the patient or legal guardian (and assent when applicable)
Who cannot join
- Refusal or inability of the patient, parents, or legal guardian to provide informed consent
- Lack of sufficient clinical data or unavailable biological samples required for the study
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
Italy10 sites, 10 recruiting
- Not yet recruiting
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Firenze
- Not yet recruiting
IRCCS Azienda Ospedaliero - Universitaria
Bologna
- Recruiting
Meyer Children's Hospital IRCCS
Florence, FIRENZE, 50139
Paola Romagnani, MD, PhD, paola.romagnani@meyer.it
Valentina Raglianti, MD, valentina.raglianti@meyer.it
- Not yet recruiting
Azienda Ospedaliero Universitaria Careggi
Florence
- Not yet recruiting
Ospedale S. Giovanni di Dio
Florence
- Not yet recruiting
IRCCS Istituto Giannina Gaslini
Genova
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma
- Not yet recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa
- Not yet recruiting
Ospedale Santo Stefano
Prato
- Not yet recruiting
Azienda USL - IRCCS
Reggio Emilia
United States1 site, 1 recruiting
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Germany1 site, 1 recruiting
- Not yet recruiting
Ludwig-Maximilians Universitat
München
Mexico1 site, 1 recruiting
- Not yet recruiting
Hospital General de México, Mexico City
Mexico City
Spain1 site, 1 recruiting
- Not yet recruiting
Bellvitge University Hospital
Barcelona
About this study
Official title: Validation and Implementation of Diagnostic Techniques for the Detection of Circulating Factors in Patients With Autoimmune Podocytopathy
Nephrotic syndrome is a kidney condition that mainly affects children and is characterized by high levels of protein in the urine, low levels of protein in the blood, and swelling. While many children respond well to steroid treatment, a large proportion experience relapses or become dependent on therapy. In some cases, the disease does not respond to standard treatments and may progress to chronic kidney disease.
Recent research suggests that, in addition to genetic factors, immune system mechanisms may play a key role in the development and progression of nephrotic syndrome. In particular, some patients produce autoantibodies against nephrin, an essential protein of the kidney filtration barrier. These autoantibodies may be associated with disease activity and treatment response.
Read more
The aim of this study is to investigate the presence of anti-nephrin autoantibodies in children with nephrotic syndrome and to better understand their role in disease mechanisms and clinical outcomes.The study will also explore the presence of other autoantibodies targeting components of the glomerular filtration barrier. The study will use advanced laboratory techniques, including blood tests and detailed analysis of kidney biopsy samples, to identify these antibodies and their relationship with kidney structure and function.
By integrating laboratory findings with clinical data, this study aims to improve the understanding of nephrotic syndrome and support the development of more personalized diagnostic and therapeutic strategies, with the goal of improving patient outcomes and reducing unnecessary or ineffective treatments.
- Conditions
- Nephrotic Syndrome With Edema (Diagnosis), Minimal Change Nephrotic Syndrome, Focal Segmental Glomerulosclerosis (FSGS), Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy
- Being tested
- Serum and renal tissue analysis
- Medical subject headings
- Disease, Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum and renal tissue analysisOther
Analysis of serum and renal biopsy material collected as part of routine clinical care. Laboratory procedures include ELISA assays for the detection of anti-nephrin and/or others anti-slit antibodies and advanced imaging techniques, such as high-resolution confocal microscopy and STED microscopy, performed for research purposes
| Study group | Role | What they receive |
|---|---|---|
| Pediatric and adult patients with podocytopathies | Experimental | Participants are not assigned to therapeutic interventions. Serum and renal biopsy samples obtained during routine clinical care are collected and analyzed for research purposes, including ELISA testing for anti-nephrin antibodies, others anti-slit antibodies and advanced microscopy evaluation. Receives: Other: Serum and renal tissue analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of anti-nephrin antibody levels
Detection of circulating anti-nephrin antibodies in serum by ELISA and localization of antibody binding in renal biopsy tissue using high-resolution confocal and STED microscopy.
Measured: From enrollment through 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start10 Jun 2025
- Primary completionOct 2034 (estimated)
- Study completionOct 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic Syndrome With Edema (Diagnosis)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are not assigned to therapeutic interventions. Biological samples and clinical data are collected within routine care.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516964
- Sponsor's protocol ID
- SLIT ABS
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Implementation of Diagnostic Techniques for the Detection of Circulating Factors in Patients With Autoimmune Podocytopathy
- ClinicalTrials.gov ID
- NCT07516964
- Acronym / sponsor ID
- SLIT ABS
- Conditions
- Nephrotic Syndrome With Edema (Diagnosis), Minimal Change Nephrotic Syndrome, Focal Segmental Glomerulosclerosis (FSGS), Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Oct 2034 (estimated)
- Study completion
- Oct 2036 (estimated)
- First posted
- 8 Apr 2026 (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.
Nephrotic syndrome is a kidney condition that mainly affects children and is characterized by high levels of protein in the urine, low levels of protein in the blood, and swelling. While many children respond well to steroid treatment, a large proportion experience relapses or become dependent on therapy. In some cases, the disease does not respond to standard treatments and may progress to chronic kidney disease.
Recent research suggests that, in addition to genetic factors, immune system mechanisms may play a key role in the development and progression of nephrotic syndrome. In particular, some patients produce autoantibodies against nephrin, an essential protein of the kidney filtration barrier. These autoantibodies may be associated with disease activity and treatment response.
The aim of this study is to investigate the presence of anti-nephrin autoantibodies in children with nephrotic syndrome and to better understand their role in disease mechanisms and clinical outcomes.The study will also explore the presence of other autoantibodies targeting components of the glomerular filtration barrier. The study will use advanced laboratory techniques, including blood tests and detailed analysis of kidney biopsy samples, to identify these antibodies and their relationship with kidney structure and function.
By integrating laboratory findings with clinical data, this study aims to improve the understanding of nephrotic syndrome and support the development of more personalized diagnostic and therapeutic strategies, with the goal of improving patient outcomes and reducing unnecessary or ineffective treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are not assigned to therapeutic interventions. Biological samples and clinical data are collected within routine care.
| Arm | Type | Receives |
|---|---|---|
| Pediatric and adult patients with podocytopathies | Experimental | Other: Serum and renal tissue analysisParticipants are not assigned to therapeutic interventions. Serum and renal biopsy samples obtained during routine clinical care are collected and analyzed for research purposes, including ELISA testing for anti-nephrin antibodies, others anti-slit antibodies and advanced microscopy evaluation. |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pediatric and adult patients with a diagnosis of podocytopathy
- Patients with nephrotic syndrome and/or histological diagnosis of minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), collapsing glomerulopathy (CG), or diffuse mesangial sclerosis (DMS)
- Both newly diagnosed (incident) patients and patients already under follow-up at participating centers
- Availability of clinical data from medical records (including paper and/or electronic records, laboratory reports, and discharge summaries)
- Availability of biological samples (e.g., blood and/or renal biopsy), if collected as part of routine clinical care
Key exclusion criteria (2 listed)
- Refusal or inability of the patient, parents, or legal guardian to provide informed consent
- Lack of sufficient clinical data or unavailable biological samples required for the study
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 |
|---|---|---|
| Serum and renal tissue analysisAnalysis of serum and renal biopsy material collected as part of routine clinical care. Laboratory procedures include ELISA assays for the detection of anti-nephrin and/or others anti-slit antibodies and advanced imaging techniques, such as high-resolution confocal microscopy and STED microscopy, performed for research purposes | Other | Pediatric and adult patients with podocytopathies |
Primary outcome
Analysis of anti-nephrin antibody levels
Time frame: From enrollment through 5 years of follow-up
Detection of circulating anti-nephrin antibodies in serum by ELISA and localization of antibody binding in renal biopsy tissue using high-resolution confocal and STED microscopy.
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 8 Apr 2026.
Related trials for Nephrotic Syndrome With Edema (Diagnosis)
Not yet recruiting
Comparison of Efficacy and Safety of Albumin Versus Fresh Frozen Plasma in Managing Diuretic Resistant Edema in Children With Idiopathic Nephrotic Syndrome.
Idiopathic Nephrotic Syndrome (INS)
RecruitingObservational study
Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
Fluid Overload, Glomerulosclerosis, Focal Segmental
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.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum and renal tissue analysis in people with Nephrotic Syndrome With Edema (Diagnosis) and Minimal Change Nephrotic Syndrome, run by Meyer Children's Hospital IRCCS at 14 sites in 5 countries.
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 6 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, United States, Germany, Mexico, Spain. 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 Paola Romagnani, MD, PhD (+39 0555662563, paola.romagnani@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of anti-nephrin antibody levels (time frame: From enrollment through 5 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.