NCT06792448Not yet recruiting
Biomarkers and Outcome Predictors of Pediatric Nephrotic Syndrome: A Genetic, Transcriptomic, and Secretome Multiomics Study
Source: ClinicalTrials.gov · Last updated 30 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Idiopathic Nephrotic Syndrome is a rare disease of the kidneys, which typically affects children. For most affected children there is the need of a prolonged treatment with drugs reducing the activity of the immune system, also resulting in many side effects. Those patients, who do not respond to treatment, are at risk of kidney damage and of dialysis or kidney transplantation. It is currently impossible to predict the response to treatment, leading to unnecessary therapies with side effects as well as unclear prognosis in the affected children. The response of the idiopathic nephrotic syndrome to medications acting on the immune system explains its important role in the occurrence of the disease. With this study we aim to obtain predictors of the response to treatment right at the beginning of the disease, to adapt the therapy avoiding needless side effects. This will be done evaluating the blood and urine of affected children using state of the art molecular characterisation. We will evaluate the genetic predisposition, the cell trait changes and the presence of molecules in blood and urine that may affect the interaction between the immune system and the kidneys. We expect that the findings will improve treatment of children with idiopathic nephrotic syndrome and reduce the number of children suffering from unnecessary drugs related side effects.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 11 Dec 2024
- Start date
- 15 Feb 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Diseases
- Chronic kidney disease
- NCT number
- NCT06792448
What you commit to
- Study type: Observational
- Planned participants: 350
- From 15 Feb 2025 to the primary completion date, 1 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with prednisone or prednisolone for nephrotic syndrome.
Other illness
- Diagnosis of secondary nephrotic syndrome.
- Presence of glomerulonephritis, autoimmune diseases, or vasculitis.
Age
- Diagnosis of congenital or infantile nephrotic syndrome (age \< 1 year).
Other
- Lack of signed informed consent by a parent or legal guardian.
Who the study is looking for
- Clinical diagnosis of idiopathic nephrotic syndrome (INS) with nephrotic range proteinuria (uPr/uCr ratio \> 2 mg/mg).
- Hypoalbuminemia with serum albumin \< 3.0 g/dL.
- Presence of edema.
- No prior treatment for idiopathic nephrotic syndrome.
- Age between 1 and 18 years at the time of enrollment.
- igned informed consent by a parent or legal guardian.
Age in the registry: - to 18 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.