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Идёт набор NCT06314230

Australian Genomics Of Chronic Allograft Dysfunction Study

— Наблюдательное Kidney Transplant Rejection Kidney Transplant; Complications

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Kidney Transplant Rejection, Kidney Transplant; Complications. Базовые параметры: 18 лет — 75 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
Австралия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study is a single centre (Westmead Hospital), prospective, observational study, which enrols patients at time of kidney (or kidney-transplant) transplant and tracks the post transplant course. The AUSCAD study aims to generate new knowledge and improve outcomes following kidney transplantation. The primary aim is to determine whether important outcomes (including chronic rejection and graft loss) are correlated with patterns of allograft reactivity, gene expression and susceptibility profiles.

Первичные конечные точки

  • Graft failure [Срок оценки: Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)]
  • Allograft rejection [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
  • Gene profile [Срок оценки: At biopsy - based on collected tissue sample]
Вторичные конечные точки (11)
  • Death [Срок оценки: At biopsy or during study follow up after biopsy (expected average over 60-months)]
  • Major infectious adverse outcomes [Срок оценки: Any time (expected average over 12-months)]
  • Major malignancy related adverse outcomes [Срок оценки: Any time (expected average over 12-months)]
  • Major cardiovascular adverse outcomes [Срок оценки: Any time (expected average over 12-months)]
  • Chronic allograft dysfunction [Срок оценки: Any time (expected average 60-months)]
  • BK virus associated nephropathy [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
  • Albuminuria [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
  • Surrogate end-points [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
  • Delayed graft function (DGF) [Срок оценки: At biopsy or during study follow up after biopsy (within 7 days of transplantation)]
  • Death censored graft loss (DCGL) [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
  • Treatment resistant rejection [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]

Критерии участия

Критерии включения

  • Living or deceased donor kidney transplant candidate.
  • Biological sex: any
  • Ages: 18-75 years.
  • Subject must be able to understand and provide informed consent.
  • Deceased donor individuals where Research Consent has been obtained from the person consenting to organ donation at the time of organ retrieval.
  • Identifiable living donors who have received informed consent and have consented to participate in the project.

Критерии исключения

  • Presensitization in living donor recipients prior to transplantation, as determined by site-specific standards, OR positive cross match according to site specific technique in cadaveric donor recipients.
  • Recipients of multiple organ transplants, with the exception of kidney/pancreas transplants.
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • High risk populations including pregnant women, children less than 18 years and prisoners will not be included in the study.
  • Non English speaking potential participants who do not understand the requirements of the study will not be included.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Австралия · 2 центра
  • Westmead Hospital — Westmead
  • Westmead Institute for Medical Research — Westmead

Идентификаторы

NCT: NCT06314230 · AUSCAD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗