Personalized diagnosis approach for nephrotic syndrome
Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome
This study is testing a new way to diagnose nephrotic syndrome to help doctors tell the difference between two types of the condition, so they can provide better treatment for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 1 Month to 40 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT06325098 on ClinicalTrials.gov |
What this trial studies
This study aims to implement a diagnostic workflow for nephrotic syndrome (NS), which encompasses various diseases caused by damage to the kidney's filtration barrier. It focuses on differentiating between steroid-sensitive nephrotic syndrome (SSNS) and steroid-resistant nephrotic syndrome (SRNS) to improve patient management and treatment outcomes. The study will utilize anti-nephrin antibodies and u-RPC cultures as part of its diagnostic approach. By providing a more accurate diagnosis, the study seeks to optimize treatment strategies and reduce the burden of unnecessary immunosuppressive therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals under 40 years of age with a clinical diagnosis of nephrotic syndrome, including both SSNS and SRNS.
Not a fit: Patients who are diagnosed with nephrotic syndrome after the age of 40 or have kidney biopsy results indicating lesions other than FSGS and MCD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and tailored treatments for patients with nephrotic syndrome, potentially improving their quality of life and reducing the risk of chronic kidney disease.
How similar studies have performed: Other studies have shown promise in utilizing personalized diagnostic approaches for nephrotic syndrome, indicating that this methodology is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of NS (SSNS, SRNS, or NS relapsed after transplantation regardless of initial response to steroid therapy) * Age below 40 years at disease onset * Availability of clinical information * Signed informed consent form Exclusion Criteria: * Age at onset above 40 years * Kidney biopsy proving lesions other than FSGS and MCD
Where this trial is running
Florence
- Meyer Children's Hospital IRCCS — Florence, Italy (Recruiting)
Study contacts
- Study coordinator: Paola Romagnani, Prof, MD, PhD
- Email: paola.romagnani@meyer.it
- Phone: 055 5662562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.