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Transcriptomic analysis of kidney biopsies has demonstrated the potential to improve diagnosis of graft rejection. Molecular assessment of kidney graft rejection based on the Banff Human Organ Transplant consensus gene panel is an available and validated tool (HistoMx). However the applicability of molecular assessment of graft biopsy in real life setting is unclear. The main objective is to assess the clinical need of molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice. The secondary objectives are to measure : clinical outcomes at 12-months follow up including patient survival, graft function and graft survival, diagnosis of graft rejection after integrating molecular assessment to standard histology, biology and immunology, and to evaluate therapeutic changes and impact on clinical outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney transplant recipients from two referral academic center were enrolled in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice | The main objective is to assess the clinical indication and rate of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Graft function at 12 months after graft biopsy | The secondary objectives are to graft function at 12 months after graft biopsy using estimated Glomerular Filtration Rate (eGFR) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of graft survival after graft biopsy | The objective is to measure probability of graft survival post graft biopsy using the iBox predictive system | 12 months |
| Rate of participants with graft rejection diagnosis based on molecular assessment of graft biopsy |
Inclusion Criteria:
Exclusion Criteria:
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Kidney transplant recipients from two French referral centers
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Lefaucheur | Paris Translational Research Center for Organ Transplantation | Principal Investigator |
| Alexandre Loupy | Paris Translational Research Center for Organ Transplantation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paris Bichat university hospital | Paris | France | ||||
| Paris Saint Louis University hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39081730 | Background | Giarraputo A, Goutaudier V, Robin B, Angelini A, Sablik M, Aubert O, Rosales IA, Smith RN, Roufosse C, Adam B, Haas M, Colvin RB, Lefaucheur C, Mengel M, Zielinski D, Loupy A. Relevance of the Banff Human Organ Transplant Consensus Gene Panel for Detecting Antibody and T-Cell-Mediated Rejection of Kidney Allografts. Kidney Int Rep. 2024 May 4;9(7):2290-2294. doi: 10.1016/j.ekir.2024.04.054. eCollection 2024 Jul. No abstract available. | |
| 40345499 |
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kidney graft biopsy
The objective is to measure the rate of participants with diagnosis of graft rejection based on molecular assessment |
| 12 months |
| Rate of participants with therapeutic changes based on graft rejection diagnosis | The objective is to measure rate of participants with therapeutic changes based on graft rejection diagnosis | 12 months |
| Paris |
| France |
| Background |
| Zielinski D, Goutaudier V, Sablik M, Divard G, Aubert O, Piedrafita A, Mezine F, Dagobert J, Certain A, Robin B, Gueguen J, Rabant M, Duong van Huyen JP, Sannier A, Randoux-Lebrun C, Maanaoui M, Lionet A, Gibier JB, Gnemmi V, Le Quintrec M, Chauveau B, Vermorel A, Couzi L, Bestard O, Elias M, Louis K, Rosales IA, Smith RN, Kung VL, Anglicheau D, Legendre C, Del Bello A, Huang E, Adam B, Kamar N, Colvin RB, Mengel M, Lefaucheur C, Loupy A. Molecular diagnosis of kidney allograft rejection based on the Banff Human Organ Transplant gene panel: A multicenter international study. Am J Transplant. 2025 Aug;25(8):1631-1642. doi: 10.1016/j.ajt.2025.04.025. Epub 2025 May 8. |