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Идёт набор NCT06342128

Molecular Landscape of Microvascular Inflammation in Kidney Allografts

— Наблюдательное Kidney Rejection Transplant

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: No intervention.
Кому может быть актуально
Состояния в реестре: Kidney Rejection Transplant. Базовые параметры: 18 лет — 100 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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Официальное название

Comprehensive Multiscale Characterization of the Molecular Landscape of Microvascular Inflammation in Kidney Allografts

Обзор

Microvascular inflammation in kidney allografts has been widely reappraised in the recent update of Banff classification. There is a critical need to better understand the pathophysiological mechanisms associated with the various phenotypes of microvascular inflammation that are observed in kidney transplants, particularly in order to develop targeted therapeutic approaches.

Подробное описание

Antibody-mediated rejection is a major cause of graft failure in kidney transplant recipients. The diagnostic criteria for antibody-mediated rejection have undergone significant changes since their initial definition in the international Banff Classification system. The Banff 2022 Classification update reappraises lesions of microvascular inflammation and identifies new phenotypes for cases with microvascular inflammation. However, pathophysiological mechanisms associated with microvascular inflammation in kidney allografts are still poorly understood, thus hampering the development of efficient treatments.

The aims of this study are:

1. To decipher the spatial immune-molecular landscape of microvascular inflammation in kidney allografts. 2. To compare the characteristics of this landscape in different clinical scenarios.

The investigators will use a multimodal phenotyping approach including histological analyses and multiplex immunostainings, bulk transcriptomic analyses and spatial whole-transcriptome digital profiling to decipher the molecular landscape of microvascular inflammation in kidney allografts. Based on these results, they will investigate its association with allograft outcomes and search for molecular targets which could benefit from targeted therapeutic strategies.

Вмешательства

  • Другое No intervention
    No intervention

Первичные конечные точки

  • RNA-based molecular signatures assessed using bulk and spatial transcriptomics [Срок оценки: 1 day (at time of a kidney allograft biopsy)]
  • Probability of graft survival based on outcome data [Срок оценки: 24 months post-kidney allograft biopsy]
  • Probability of patient survival on outcome data [Срок оценки: 24 months post-kidney allograft biopsy]

Критерии участия

Критерии включения

\- Adult kidney transplant recipients, with at least one kidney transplant biopsy performed and assessed according to the international Banff 2022 classification, with or without lesions of microvascular inflammation

Критерии исключения

  • Inadequate biopsy according to the Banff classification
  • Missing data for Banff lesion scores, donor-specific antibody status, C4d staining
  • Biopsies showing histological signs of ischemia-reperfusion
  • Combined transplantation and kidney transplantation after a non-kidney solid organ transplantation

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 · 3 центра
  • Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Pari — Paris
  • Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris — Paris
  • Bichat Hospital, Assistance Publique - Hôpitaux de Paris — Paris

Публикации

  • Loupy A, Haas M, Roufosse C, Naesens M, Adam B, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell LD, Clahsen-van Groningen MC, Demetris AJ, Dragun D, Duong van Huyen JP, Farris AB, Fogo AB, Gibson IW, Glotz D, Gueguen J, Kikic Z, Kozakowski N, Kraus E, Lefaucheur C, Liapis H, Mannon RB, Montgomery RA, Nankivell BJ, Nickeleit V, Nickerson P, Rabant M, Racusen L, Randhawa P, Robin B PMID 32463180
  • Mengel M, Loupy A, Haas M, Roufosse C, Naesens M, Akalin E, Clahsen-van Groningen MC, Dagobert J, Demetris AJ, Duong van Huyen JP, Gueguen J, Issa F, Robin B, Rosales I, Von der Thusen JH, Sanchez-Fueyo A, Smith RN, Wood K, Adam B, Colvin RB. Banff 2019 Meeting Report: Molecular diagnostics in solid organ transplantation-Consensus for the Banff Human Organ Transplant (B-HOT) gene panel and open so PMID 32428337
  • Loupy A, Mengel M, Haas M. Thirty years of the International Banff Classification for Allograft Pathology: the past, present, and future of kidney transplant diagnostics. Kidney Int. 2022 Apr;101(4):678-691. doi: 10.1016/j.kint.2021.11.028. Epub 2021 Dec 17. PMID 34922989
  • Naesens M, Roufosse C, Haas M, Lefaucheur C, Mannon RB, Adam BA, Aubert O, Bohmig GA, Callemeyn J, Clahsen-van Groningen M, Cornell LD, Demetris AJ, Drachenberg CB, Einecke G, Fogo AB, Gibson IW, Halloran P, Hidalgo LG, Horsfield C, Huang E, Kikic Z, Kozakowski N, Nankivell B, Rabant M, Randhawa P, Riella LV, Sapir-Pichhadze R, Schinstock C, Solez K, Tambur AR, Thaunat O, Wiebe C, Zielinski D, Col PMID 38032300

Идентификаторы

NCT: NCT06342128 · MVI_Kidney_001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗