Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
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: Biological samples collection.
- Кому может быть актуально
- Состояния в реестре: Acute Kidney Injury, Chronic Kidney Diseases, Solid-organ Transplantation, Cancer. Базовые параметры: 18 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer…). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases.
Подробное описание
Acute renal failure (ARF) and chronic kidney disease (CKD) are frequent pathologies (850 million people are affected worldwide). Renal failure is associated with an increased morbidity and mortality, including an increased risk of infections, drug toxicity and cardiovascular death. The causes of renal failure are numerous: metabolic (diabetes, hypertension), immunological (autoimmune diseases, monoclonal gammopathies), toxic (environment, drugs), genetic, infectious, ischemic, paraneoplastic... Any episode of ARF is also accompanied by a risk of secondary CKD (relative risk multiplied by 9).
The mechanisms leading to renal failure are multiple and combine predisposing genetic factors, inadequate intra-renal or systemic immune response, endothelial and epithelial dysfunctions, and potentially inappropriate regenerative capacity. In addition, renal failure or its treatment itself may be accompanied by additional renal lesions (e.g. nephrotoxicity of calcineurin inhibitors used as anti-rejection treatment in transplantation, hemodynamic intolerance with secondary ARF during hemodialysis sessions, iatrogenic ARF when using diuretics or inhibitors of the renin angiotensin system) or extra-renal complications (e.g. immunosuppression and infections induced by immunomodulatory therapies during autoimmune diseases or for prevention of transplant rejection; vascular diseases secondary to phosphocalcic disorders).
Patients included in the NEPHROGENE 2.0 cohort will be followed during 10 years and clinical data and biological samples will be collected at the inclusion in the cohort, at each monitoring programmed in their usual care and and at each event (infection, acute kidney injury, cancer…). Samples will be collected according to the symptoms of the patients.
Вмешательства
- Биопрепарат Biological samples collection
SOT patients: samples will be collected at the time of the protocol follow-up visit (registration on the transplant list, on the day of the transplantation, and then at day 15, month 1-3-6-9-12 and then annually, as well as if complications or therapeutic modifications). Dialysis patients: at the start of the dialysis and then at M3, M12, and if complications or modification of the dialysis protocol. Non-dialysis or cancer patients: the sampling frequency will be individualized according to th
Первичные конечные точки
- Identification of the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases. [Срок оценки: yearly and up to 10 years after inclusion in the study]
Вторичные конечные точки (3)
- Identification of the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases [Срок оценки: up to 10 years after inclusion in the study]
- Identification of the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases [Срок оценки: up to 10 years after inclusion in the study]
- To specify the individual risk of complications secondary to SOT or its treatment [Срок оценки: up to 10 years after inclusion in the study]
Критерии участия
Критерии включения
- Patients (> 18 year of age) with kidney disease or at risk to develop a kidney disease,
- Patients followed by a practitioner of the Department of Nephrology and Organ Transplantations of the University Hospital of Toulouse (France)
Критерии исключения
- consent deny
- inability of the patient or its family to give consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Rangueil University Hospital — Toulouse
Идентификаторы
NCT: NCT05318196 · RC31/21/0154