Molecular Landscape of Microvascular Inflammation in Kidney Allografts

NCT06342128 | Recruiting

• 1 other identifier: MVI_Kidney_001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Kidney Rejection Transplant

Outcome Measures

Primary Outcomes (3)

• RNA-based molecular signatures assessed using bulk and spatial transcriptomics

  1 day (at time of a kidney allograft biopsy)

• Probability of graft survival based on outcome data

  24 months post-kidney allograft biopsy

• Probability of patient survival on outcome data

  24 months post-kidney allograft biopsy

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult kidney transplant recipients of all sexes (self-determined) recruited in Europe and United States, who had a kidney allograft biopsy with or without lesions of microvascular inflammation (adequate biopsies without missing data for Banff lesion scores, donor-specific antibody status, and C4d staining), according to the international Banff 2022 classification.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (3)

Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris

Paris, 75010, France

RECRUITING

Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris

Paris, 75015, France

RECRUITING

Bichat Hospital, Assistance Publique - Hôpitaux de Paris

Paris, 75018, France

RECRUITING

Related Publications (4)

• 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, Rosales IA, Sapir-Pichhadze R, Schinstock CA, Seron D, Singh HK, Smith RN, Stegall MD, Zeevi A, Solez K, Colvin RB, Mengel M. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell- and antibody-mediated rejection. Am J Transplant. 2020 Sep;20(9):2318-2331. doi: 10.1111/ajt.15898. Epub 2020 May 28.

  PMID: 32463180 BACKGROUND

• 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 source multicenter validation. Am J Transplant. 2020 Sep;20(9):2305-2317. doi: 10.1111/ajt.16059. Epub 2020 Jun 27.

  PMID: 32428337 BACKGROUND

• 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 BACKGROUND

• 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, Colvin R, Loupy A, Mengel M. The Banff 2022 Kidney Meeting Report: Reappraisal of microvascular inflammation and the role of biopsy-based transcript diagnostics. Am J Transplant. 2024 Mar;24(3):338-349. doi: 10.1016/j.ajt.2023.10.016. Epub 2023 Oct 28.

  PMID: 38032300 BACKGROUND

Central Study Contacts

Alexandre Loupy, MD PhD

CONTACT

+33612491082; alexandreloupy@inserm.fr

Catherine Tritscher

CONTACT

+33153988000; tritschercatherine@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: January 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2024-11

Locations

FR (3)