Transplant;Failure,KidneyNCT06496269
Impact of Microvascular Inflammation on Kidney Allograft Outcome
An observational study of Transplant;Failure,Kidney and Kidney Transplant Rejection, run by Paris Translational Research Center for Organ Transplantation at 19 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transplant;Failure,Kidney, Kidney Transplant Rejection
- How many people
- 6,000 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Kidney transplant recipients, with at least one kidney transplant biopsy performed, assessed with the Banff classification.
Who cannot join
- Missing data for a rejection-related diagnosis according to the 2019 and 2022 Banff classification.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
France9 sites
Bordeaux University Hospital, Department of Nephrology, Transplantation, Dialysis and Apheresis
Bordeaux
Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon
Lyon
Department of Nephrology, Centre Hospitalier Universitaire de Montpellier
Montpellier
Nantes University Hospital, Department of Nephrology
Nantes
Division of Pediatric Nephrology, Necker Hospital, AP-HP
Paris
Division of Pediatric Nephrology, Robert Debré Hospital, AP-HP
Paris
Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris
Paris
Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris
Paris
Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Toulouse
Toulouse
United States7 sites
Division of Pediatric Nephrology, Children's Pediatric Institute
Atlanta, Georgia, 30329
Acute Dialysis Units, Pediatric Kidney Transplant
Charleston, South Carolina, 29425
Division of Pediatric Nephrology, Children's Mercy Hospital
Kansas City, Missouri, 64108
Pediatric Nephrology, UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Division of Nephrology, Department of Medicine, University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
Division of Pediatric Nephrology and Hypertension, Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Department of Pediatrics, Seattle Children's Hospital
Seattle, Washington, 98105
Germany1 site
Department of Nephrology and Critical Care Medicine, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Berlin Institute of Health
Berlin
Spain1 site
Department of Nephrology and Kidney Transplantation, Vall d'Hebrón University Hospital
Barcelona
Switzerland1 site
Division of Abdominal and Transplantation Surgery, Department of Surgery, Geneva University Hospitals,
Geneva
About this study
Official title: Impact of Microvascular Inflammation on Kidney Allograft Outcome: a Multinational Cohort Study
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.
Read the detailed description
Antibody-mediated rejection is a major cause of graft failure in kidney transplant recipients, with allograft microvascular inflammation serving as the hallmark histological lesion of antibody-mediated graft injury. However, the frequent occurrence of graft microvascular inflammation in the absence of circulating anti-HLA donor-specific antibodies highlights the incomplete understanding of the mechanisms underlying this inflammation. This heterogenous presentation poses a significant challenge in the clinical setting, as current treatment strategies often prove ineffective, hindering the improvement of allograft and patient care. The Banff 2022 classification update has reappraised lesions of microvascular inflammation, identifying new diagnostic phenotypes of microvascular inflammation. However, the clinical significance of these phenotypes is yet to be determined.
The aims of this study are:
- To determine the impact of the revised Banff 2022 Classification on the diagnostic classification of phenotypes related to microvascular inflammation, compared to previous Banff 2019 Classification.
- To assess the association of microvascular inflammation phenotypes with kidney allograft survival.
- To assess the association of microvascular inflammation phenotypes with disease progression, defined by transplant glomerulopathy occurrence (cg and subsequent antibody-mediated rejection episodes.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular inflammation-related diagnoses according to the Banff 2022 Classification
Measured: March 2004 to December 2023
Kidney allograft loss
Measured: March 2004 to December 2023
Secondary outcomes (2)
Transplant glomerulopathy
Measured: March 2004 to December 2023
(Recurrent) antibody-mediated rejection episode
Measured: March 2004 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transplant;Failure,KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Loupy, Principal investigator, Paris Institute for Transplantation and Organ Regeneration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496269
- Sponsor's protocol ID
- MVI_Kidney_002
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data analyzed during the current study are available on reasonable request including standards for General Data Protection Regulation and Institutional Review Board approval.
Publications
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.
PubMed 39450752
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Microvascular Inflammation on Kidney Allograft Outcome: a Multinational Cohort Study
- ClinicalTrials.gov ID
- NCT06496269
- Acronym / sponsor ID
- MVI_Kidney_002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Antibody-mediated rejection is a major cause of graft failure in kidney transplant recipients, with allograft microvascular inflammation serving as the hallmark histological lesion of antibody-mediated graft injury. However, the frequent occurrence of graft microvascular inflammation in the absence of circulating anti-HLA donor-specific antibodies highlights the incomplete understanding of the mechanisms underlying this inflammation. This heterogenous presentation poses a significant challenge in the clinical setting, as current treatment strategies often prove ineffective, hindering the improvement of allograft and patient care. The Banff 2022 classification update has reappraised lesions of microvascular inflammation, identifying new diagnostic phenotypes of microvascular inflammation. However, the clinical significance of these phenotypes is yet to be determined.
The aims of this study are:
- To determine the impact of the revised Banff 2022 Classification on the diagnostic classification of phenotypes related to microvascular inflammation, compared to previous Banff 2019 Classification.
- To assess the association of microvascular inflammation phenotypes with kidney allograft survival.
- To assess the association of microvascular inflammation phenotypes with disease progression, defined by transplant glomerulopathy occurrence (cg and subsequent antibody-mediated rejection episodes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Kidney transplant recipients, with at least one kidney transplant biopsy performed, assessed with the Banff classification.
Key exclusion criteria (1 listed)
- Missing data for a rejection-related diagnosis according to the 2019 and 2022 Banff classification.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Microvascular inflammation-related diagnoses according to the Banff 2022 Classification
Time frame: March 2004 to December 2023
Kidney allograft loss
Time frame: March 2004 to December 2023
2 secondary outcomes
Transplant glomerulopathy
Time frame: March 2004 to December 2023
(Recurrent) antibody-mediated rejection episode
Time frame: March 2004 to December 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 39450752Sablik 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.
- Individual participant dataSharing planned: Undecided. The data analyzed during the current study are available on reasonable request including standards for General Data Protection Regulation and Institutional Review Board approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Loupy principal investigator
Paris Institute for Transplantation and Organ Regeneration
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant;Failure,Kidney and Kidney Transplant Rejection, run by Paris Translational Research Center for Organ Transplantation at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, United States, Germany, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular inflammation-related diagnoses according to the Banff 2022 Classification (time frame: March 2004 to December 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.