Actively Recruiting
Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome
Led by Meyer Children's Hospital IRCCS · Updated on 2024-03-22
150
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Nephrotic syndrome (NS) is a condition caused by damage to kidney cells called podocytes and the filtration barrier. This trial focuses on improving diagnosis and personalized treatment for patients with NS, including those who respond well to steroids (steroid-sensitive nephrotic syndrome, SSNS) and those who do not (steroid-resistant nephrotic syndrome, SRNS). The study aims to better understand immunological factors and improve management to prevent progression to kidney failure. It is sponsored by Meyer Children's Hospital IRCCS and involves patients up to 40 years old. The trial includes two groups: patients with SSNS or those with post-transplant NS recurrence will have blood samples taken to study immune factors like anti-nephrin antibodies. Patients with SRNS will undergo genetic testing and provide blood and urine samples to study immune factors and urine-derived renal progenitor cells (u-RPC) cultures. These samples will be analyzed using organ-on-a-chip models and advanced microscopy. The study is non-randomized and does not involve masking. Participants will be followed for up to 12 months after enrollment. Researchers will assess the role of anti-nephrin antibodies and genetic variants in NS, identify biomarkers predicting kidney outcomes, and analyze cost-effectiveness. Participants will provide clinical data, blood, and urine samples during their visits. The study does not involve healthy volunteers and aims to improve personalized diagnosis and treatment for NS patients.
CONDITIONS
Brief Title
Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of nephrotic syndrome including steroid-sensitive, steroid-resistant, or post-transplant relapse
- Age below 40 years at disease onset
- Availability of clinical information
- Signed informed consent form
You will not qualify if you...
- Age at onset above 40 years
- Kidney biopsy showing lesions other than focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months from enrollment
Participants provide serum and urine samples for analysis of anti-nephrin antibodies and u-RPC cultures to personalize diagnosis of nephrotic syndrome.
Multiple visits depending on sampling schedules
Duration - Up to 12 months from enrollment
Participants are monitored to assess biomarkers and outcomes related to nephrotic syndrome over time.
Follow-up visits as scheduled over 12 months
Trial Site Locations
Total: 1 location
1
Meyer Children's Hospital IRCCS
Florence, Italy
Actively Recruiting
Research Team
P
Paola Romagnani, Prof, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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