Service de Néphrologie et Dialyses, Hôpital Tenon
Paris, France, 75020
Location status: Recruiting
Location contact
Alexandre LAHENS, Dr
CONTACT
Jean-Jacques BOFFA, Pr
CONTACT
NCT Number: NCT06820866
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, France, 75020
Location status: Recruiting
Alexandre LAHENS, Dr
CONTACT
Jean-Jacques BOFFA, Pr
CONTACT
Medical management will not be altered by the protocol, and patients will be treated according to the practices of each center.
The investigator will offer participation in the study to all eligible consecutive patients in their center. They will provide an information sheet and answer any questions the patient may have. After obtaining the patient's non-opposition, the following clinical and biological data will be collected:
(Age, sex, medical and surgical history, BMI at admission, systolic and diastolic blood pressure at admission, presence of lower limb edema, CBC, blood electrolyte levels, urea, creatinine, albumin levels, urinary electrolytes, proteinuria, albuminuria, urine culture, antinuclear antibodies, serum protein electrophoresis, serum protein immunofixation, complement fractions C3 and C4, lipid profile).
The SNIT calculation will be performed automatically in the CRF from the variables it comprises, but will not be visible to the investigator.
As part of patient care, patients will be followed up one month after inclusion. During this visit, the evolving biological data (creatinine, albumin levels, proteinuria, albuminuria) and the treatment administered will be collected from the patient's medical records.
The final diagnosis will be collected as soon as it is available (within a maximum of 4 months for the completion and reporting of the histopathological results). Histological data will be collected from the report of the pathologist who examined the renal biopsy (available in the medical record). (In the case of INS: presence or absence of segmental and focal hyalinosis lesions, percentage of fibrosis).
The objectives of this study will be :
Duration of participant involvement and study duration:
The inclusion period will be 24 months. The follow-up period for participants will be a maximum of 4 months (until the histological diagnosis is returned). Therefore, the total duration of the research will be a maximum of 28 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 months
Time frame: 4 months
Time frame: 4 months
Time frame: 4 months
The theoretical number of hospitalization days with the use of SNIT (i.e., estimated from the CRH data, subtracting the days of hospitalization required for renal biopsy in the case of a positive test).
Adverse effects of corticosteroid treatment: infections, edema syndrome, corticosteroid-induced diabetes, heart failure decompensation.
Contact information is provided by the study sponsor or research team.
Alexandre LAHENS, Dr
CONTACT
Jean-Jacques BOFFA, Pr
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Non-invasive Diagnosis of Idiopathic Nephrotic Syndromes : DNI-SNI
Acronym: DNI-SNI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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