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Идёт набор NCT07516964

SLIT ABS: Study on Patients With Autoimmune Podocytopathy

Без фазы С лечением Nephrotic Syndrome With Edema (Diagnosis) Minimal Change Nephrotic Syndrome Focal Segmental Glomerulosclerosis (FSGS) Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Serum and renal tissue analysis.
Кому может быть актуально
Состояния в реестре: Nephrotic Syndrome With Edema (Diagnosis), Minimal Change Nephrotic Syndrome, Focal Segmental Glomerulosclerosis (FSGS), Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy. Базовые параметры: 0 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Германия, Италия, Мексика, Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Validation and Implementation of Diagnostic Techniques for the Detection of Circulating Factors in Patients With Autoimmune Podocytopathy

Обзор

Nephrotic syndrome is a kidney condition that mainly affects children and is characterized by high levels of protein in the urine, low levels of protein in the blood, and swelling. While many children respond well to steroid treatment, a large proportion experience relapses or become dependent on therapy. In some cases, the disease does not respond to standard treatments and may progress to chronic kidney disease. Recent research suggests that, in addition to genetic factors, immune system mechanisms may play a key role in the development and progression of nephrotic syndrome. In particular, some patients produce autoantibodies against nephrin, an essential protein of the kidney filtration barrier. These autoantibodies may be associated with disease activity and treatment response. The aim of this study is to investigate the presence of anti-nephrin autoantibodies in children with nephrotic syndrome and to better understand their role in disease mechanisms and clinical outcomes.The study will also explore the presence of other autoantibodies targeting components of the glomerular filtration barrier. The study will use advanced laboratory techniques, including blood tests and detailed analysis of kidney biopsy samples, to identify these antibodies and their relationship with kidney structure and function. By integrating laboratory findings with clinical data, this study aims to improve the understanding of nephrotic syndrome and support the development of more personalized diagnostic and therapeutic strategies, with the goal of improving patient outcomes and reducing unnecessary or ineffective treatments.

Вмешательства

  • Другое Serum and renal tissue analysis
    Analysis of serum and renal biopsy material collected as part of routine clinical care. Laboratory procedures include ELISA assays for the detection of anti-nephrin and/or others anti-slit antibodies and advanced imaging techniques, such as high-resolution confocal microscopy and STED microscopy, performed for research purposes

Первичные конечные точки

  • Analysis of anti-nephrin antibody levels [Срок оценки: From enrollment through 5 years of follow-up]

Критерии участия

Критерии включения

  • Pediatric and adult patients with a diagnosis of podocytopathy
  • Patients with nephrotic syndrome and/or histological diagnosis of minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), collapsing glomerulopathy (CG), or diffuse mesangial sclerosis (DMS)
  • Both newly diagnosed (incident) patients and patients already under follow-up at participating centers
  • Availability of clinical data from medical records (including paper and/or electronic records, laboratory reports, and discharge summaries)
  • Availability of biological samples (e.g., blood and/or renal biopsy), if collected as part of routine clinical care
  • Signed informed consent by the patient or legal guardian (and assent when applicable)

Критерии исключения

  • Refusal or inability of the patient, parents, or legal guardian to provide informed consent
  • Lack of sufficient clinical data or unavailable biological samples required for the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Италия · 10 центров
  • Ospedale Santa Maria Annunziata — Bagno a Ripoli
  • Meyer Children's Hospital IRCCS — Florence
  • IRCCS Azienda Ospedaliero - Universitaria — Bologna
  • Azienda Ospedaliero Universitaria Careggi — Florence
  • Ospedale S. Giovanni di Dio — Florence
  • IRCCS Istituto Giannina Gaslini — Genova
  • Azienda Ospedaliero-Universitaria di Parma — Parma
  • Azienda Ospedaliero Universitaria Pisana — Pisa
  • … и ещё 2 центра
США · 1 центр
  • Mayo Clinic — Rochester
Германия · 1 центр
  • Ludwig-Maximilians Universitat — München
Мексика · 1 центр
  • Hospital General de México, Mexico City — Mexico City
Испания · 1 центр
  • Bellvitge University Hospital — Barcelona

Идентификаторы

NCT: NCT07516964 · SLIT ABS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗