Multitarget Strategy for Primary Podocytopathies

Обзор

The goal of this clinical trial is to verify whether a cell culture system can be used to evaluate the presence of a factor capable of causing proteinuria in the serum of patients with primary podocytopathies. This system will also be used to evaluate the in vitro efficacy of a combined therapy for the treatment of this disorder. Researchers will compare samples from patients with primary podocytopathies with those obtained from healthy subjects and patients with other renal disorders. Participants will be asked to visit the clinic at regular intervals for up to 36 months, and to provide blood and urine samples (and a sample of the discarded plasmapheresis effluent in case the procedure is performed).

Вмешательства

• Другое Biologic fluid sampling
  The only interventions in addition to standard clinical practice will be blood sampling, the collection of morning spot urine and the collection of the discarded effluent of the plasmapheresis procedure (when performed according to clinical indication).

Первичные конечные точки

• Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects [Срок оценки: Baseline]

Вторичные конечные точки (3)

• In-vitro efficacy of SGLT2-inhibitors and uPAR/FPR-inhibitors on primary podocytopathies [Срок оценки: Baseline, 16 weeks and in case of remission/recurrence]
• Co-culture system capability to distinguish recurrent podocytopathies from other glomerular disorders [Срок оценки: Baseline]
• Co-culture system reliability in case of podocytopathy remission [Срок оценки: Baseline, 16 weeks and in case of remission/recurrence]

Критерии участия

Критерии включения

• Signature of informed consent for study participation
• One of the following conditions:

• Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) showing clinical and/or histological evidence of post-transplant recurrence.
• Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) without clinical and/or histological evidence of post-transplant recurrence.
• Patients with primary podocytopathies in their native kidneys in an active clinical phase of the disease.
• Patients with podocytopathies presenting clinical features compatible with a secondary form due to another condition.
• Patients with glomerulonephritis other than primary podocytopathies (e.g., IgA nephropathy, systemic lupus erythematosus, membranous nephropathy).
• Patients with no history of renal diseases

Критерии исключения

• Subjects affected by primary podocytopathies or other glomerulonephritides in clinical remission or with ESRD (eGFR < 15 ml/min) and/or on renal replacement therapy
• Individuals unable to understand and consent to the study procedures
• Any clinical condition that, according to the investigator's judgment, could compromise patient safety during study participation

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Италия · 2 центра

• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
• Fondazione IRCCS Policlinico San Matteo — Pavia

Идентификаторы

NCT: NCT06718894 · 5387

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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