Actively Recruiting

Phase Not Applicable
Age: 0Years - 99Years
All Genders
ID07516964

Validation and Implementation of Diagnostic Techniques for the Detection of Circulating Factors in Patients With Autoimmune Podocytopathy

Led by Meyer Children's Hospital IRCCS · Updated on 2026-04-08

50

Participants Needed

14

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Nephrotic syndrome is a kidney disorder mainly affecting children, characterized by high protein levels in urine, low protein levels in blood, and swelling. Many children respond to steroid treatment, but some experience relapses, become dependent on therapy, or do not respond to standard treatments, potentially leading to chronic kidney disease. Research suggests that immune system factors, especially autoantibodies against nephrin, a key kidney protein, may influence disease activity and treatment response. This study investigates the presence of anti-nephrin autoantibodies and other autoantibodies targeting kidney filtration components in children and adults with nephrotic syndrome. Researchers will collect and analyze serum and kidney biopsy samples obtained during routine care using advanced laboratory techniques, including ELISA testing and high-resolution microscopy, to better understand these antibodies and their link to kidney structure and function. Participants will provide clinical data and biological samples collected as part of their usual care. The study will analyze anti-nephrin antibody levels from enrollment through five years of follow-up. Data from medical records and laboratory tests will be integrated to explore disease mechanisms and outcomes. This research aims to improve diagnosis and treatment personalization while reducing ineffective therapies.

CONDITIONS

Brief Title

SLIT ABS: Study on Patients With Autoimmune Podocytopathy

Who Can Participate

Age: 0Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric and adult patients diagnosed with podocytopathy
  • Patients with nephrotic syndrome or histological diagnosis of minimal change disease, focal segmental glomerulosclerosis, collapsing glomerulopathy, or diffuse mesangial sclerosis
  • Both newly diagnosed and patients already under follow-up at participating centers
  • Availability of clinical data from medical records and laboratory reports
  • Availability of biological samples such as blood or renal biopsy collected during routine care
  • Signed informed consent by patient or legal guardian, with assent when applicable
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants who undergo routine care are observed through analysis of serum and renal biopsy samples collected during routine clinical care for research purposes.

Follow-up visits aligned with routine clinical care for sample collection and data analysis

Trial Site Locations

Total: 14 locations

1

Mayo Clinic

Rochester, Minnesota, United States, 55902

Not Yet Recruiting

2

Ludwig-Maximilians Universitat

München, Germany

Not Yet Recruiting

3

Ospedale Santa Maria Annunziata

Bagno a Ripoli, Firenze, Italy

Not Yet Recruiting

4

Meyer Children's Hospital IRCCS

Florence, FIRENZE, Italy, 50139

Actively Recruiting

5

IRCCS Azienda Ospedaliero - Universitaria

Bologna, Italy

Not Yet Recruiting

6

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Not Yet Recruiting

7

Ospedale S. Giovanni di Dio

Florence, Italy

Not Yet Recruiting

8

IRCCS Istituto Giannina Gaslini

Genova, Italy

Not Yet Recruiting

9

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Not Yet Recruiting

10

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Not Yet Recruiting

11

Ospedale Santo Stefano

Prato, Italy

Not Yet Recruiting

12

Azienda USL - IRCCS

Reggio Emilia, Italy

Not Yet Recruiting

13

Hospital General de México, Mexico City

Mexico City, Mexico

Not Yet Recruiting

14

Bellvitge University Hospital

Barcelona, Spain

Not Yet Recruiting

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Research Team

P

Paola Romagnani, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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