Non-invasive Diagnosis of Idiopathic Nephrotic Syndromes

Recruiting now

Conditions studied: Idiopathic Nephrotic Syndrome (INS)

In brief

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.

Key facts

Study ID: NCT06820866
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 265
Starts: 2025-04-15
Expected to finish: 2027-08-01
Last updated by the study team: 2025-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Patients with known lupus nephropathy (prior to the current episode)
Patients with known IgA nephropathy (prior to the current episode)

Where it is running

Service de Néphrologie et Dialyses, Hôpital Tenon — Paris, France, France (enrolling)

Full record on ClinicalTrials.gov

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