NCT06820866 Non-invasive Diagnosis of Idiopathic Nephrotic Syndromes
| NCT ID | NCT06820866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Idiopathic Nephrotic Syndrome (INS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 265 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 265 participants in total. It began in 2025-04-15 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Renal biopsy (RB) is the reference diagnostic procedure for Idiopathic Nephrotic Syndrome (INS). It is an invasive procedure, particularly risky during the acute phase of nephrotic syndrome when anticoagulation therapy is required. By identifying serum antibodies that allow for the non-invasive diagnosis of the main differential diagnoses of INS, (Membranous Nephropathy), the development of a non-invasive diagnostic tool for INS could help reduce the morbidity associated with the invasive renal biopsy procedure, minimizing the risk of incorrect diagnosis. We developed a diagnostic score, the SNIT, from routine clinical and biological variables to allow INS diagnoses in patients for whom detection of blood antibodies of Membranous Nephropathy were negative. The main goal of this study is to validate this diagnosis score in a prospective study, to allow INS diagnosis without renal biopsy.
Eligibility Criteria
Inclusion Criteria: * Patients aged 18 years and older * Hospitalized for a first episode of nephrotic syndrome (proteinuria greater than 3g/g and albumin level \< 30g/L) * Negative anti-PLA2r antibodies in the blood * Requirement for a renal biopsy for diagnostic purposes Exclusion Criteria: * Patients with known lupus nephropathy (prior to the current episode) * Patients with known IgA nephropathy (prior to the current episode)
Contact & Investigator
Alexandre LAHENS, Dr
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06820866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Idiopathic Nephrotic Syndrome (INS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06820866 currently recruiting?
Yes, NCT06820866 is actively recruiting participants. Contact the research team at alexandre.lahens@aphp.fr for enrollment information.
Where is the NCT06820866 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06820866 clinical trial?
NCT06820866 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Alexandre LAHENS, Dr at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 265 participants.