50 Participants NeededMy employer runs this trial

Serum and Renal Tissue Analysis for Nephrotic Syndrome

Recruiting at 13 trial locations
PR
Overseen ByPaola Romagnani, MD, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Meyer Children's Hospital IRCCS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Availability of biological samples (e.g., blood and/or renal biopsy), if collected as part of routine clinical care
I have been diagnosed with podocytopathy.
I have nephrotic syndrome or a kidney disease like MCD, FSGS, CG, or DMS.
See 3 more

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection and Analysis

Serum and renal biopsy samples are collected and analyzed for research purposes, including ELISA testing for anti-nephrin antibodies and advanced microscopy evaluation.

Ongoing throughout study

Follow-up

Participants are monitored for safety and effectiveness after sample collection and analysis

5 years

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Pediatric and adult patients with podocytopathiesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Meyer Children's Hospital IRCCS

Lead Sponsor

Trials
62
Recruited
17,500+