SLIT ABS: Study on Patients With Autoimmune Podocytopathy

Conditions

• Focal Segmental Glomerulosclerosis (FSGS)
• Minimal Change Nephrotic Syndrome
• Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy
• Nephrotic Syndrome With Edema (Diagnosis)

Eligibility Criteria

Sex

ALL

Age

0 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Serum and renal tissue analysis — OTHER
  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 Details

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.

Key Dates

Start date

Jun 10, 2025

Status verified

Apr 2026

Primary completion

Oct 31, 2034

Completion

Oct 31, 2036

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Pediatric and adult patients with podocytopathies
  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.

Primary Outcome Measure

Analysis of anti-nephrin antibody levels [ Time Frame: From enrollment through 5 years of follow-up ]

Central Contacts

• Paola Romagnani, MD, PhD
  +39 0555662563
  [email protected]

Locations (1)

Find similar trials in Rochester, MN

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