Impact of Microvascular Inflammation on Kidney Allograft Outcome

NCT06496269 | Completed

• 1 other identifier: MVI_Kidney_002
• Study Type: observational
• Target: 6,000
• Locations: 5 countries
• Sites: 19

Brief Summary

Graft microvascular inflammation poses a significant challenge to successful kidney transplantation due to its heterogeneous clinical presentation. There is a critical need to unravel the clinical significance of newly defined allograft microvascular inflammation phenotypes in the Banff 2022 classification and assess the implications of these new phenotypes on kidney transplant precision diagnostics and patient risk stratification.

Conditions

Transplant;Failure,Kidney; Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (2)

• Microvascular inflammation-related diagnoses according to the Banff 2022 Classification

  March 2004 to December 2023

• Kidney allograft loss

  March 2004 to December 2023

Secondary Outcomes (2)

• Transplant glomerulopathy

  March 2004 to December 2023

• (Recurrent) antibody-mediated rejection episode

  March 2004 to December 2023

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients of all sexes recruited in observational studies performed in Europe and United States, with at least one kidney biopsy performed with all the relevant data to provide a diagnosis according to the 2019 and 2022 Banff classification, including clinical data (recipient and donor's age, sex and transplant characteristics).

You may qualify if:

• Kidney transplant recipients, with at least one kidney transplant biopsy performed, assessed with the Banff classification.

You may not qualify if:

• Missing data for a rejection-related diagnosis according to the 2019 and 2022 Banff classification.

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (19)

Pediatric Nephrology, UCLA Mattel Children's Hospital

Los Angeles, California, 90095, United States

Location

Division of Pediatric Nephrology, Children's Pediatric Institute

Atlanta, Georgia, 30329, United States

Location

Division of Pediatric Nephrology, Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Acute Dialysis Units, Pediatric Kidney Transplant

Charleston, South Carolina, 29425, United States

Location

Division of Pediatric Nephrology and Hypertension, Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Department of Pediatrics, Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Division of Nephrology, Department of Medicine, University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

Location

Bordeaux University Hospital, Department of Nephrology, Transplantation, Dialysis and Apheresis

Bordeaux, France

Location

Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon

Lyon, France

Location

Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Location

Nantes University Hospital, Department of Nephrology

Nantes, France

Location

Division of Pediatric Nephrology, Necker Hospital, AP-HP

Paris, France

Location

Division of Pediatric Nephrology, Robert Debré Hospital, AP-HP

Paris, France

Location

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

Paris, France

Location

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

Paris, France

Location

Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

Department of Nephrology and Critical Care Medicine, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Berlin Institute of Health

Berlin, Germany

Location

Department of Nephrology and Kidney Transplantation, Vall d'Hebrón University Hospital

Barcelona, Spain

Location

Division of Abdominal and Transplantation Surgery, Department of Surgery, Geneva University Hospitals,

Geneva, Switzerland

Location

Related Publications (1)

• Sablik M, Sannier A, Raynaud M, Goutaudier V, Divard G, Astor BC, Weng P, Smith J, Garro R, Warady BA, Zahr RS, Twombley K, Dharnidharka VR, Dandamudi RS, Fila M, Huang E, Sellier-Leclerc AL, Tonshoff B, Rabant M, Verine J, Del Bello A, Berney T, Boyer O, Catar RA, Danger R, Giral M, Yoo D, Girardin FR, Alsadi A, Gourraud PA, Morelon E, Le Quintrec M, Try M, Villard J, Zhong W, Bestard O, Budde K, Chauveau B, Couzi L, Brouard S, Hogan J, Legendre C, Anglicheau D, Aubert O, Kamar N, Lefaucheur C, Loupy A. Microvascular Inflammation of Kidney Allografts and Clinical Outcomes. N Engl J Med. 2025 Feb 20;392(8):763-776. doi: 10.1056/NEJMoa2408835. Epub 2024 Oct 24.

  PMID: 39450752 DERIVED

Study Officials

• Alexandre Loupy

  Paris Institute for Transplantation and Organ Regeneration

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

US (7); DE (1); FR (9); CH (1); ES (1)