Molecular HistoMx Assessment for Kidney Transplant Rejection and Management

NCT ID: NCT07347353

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Graft Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney transplant recipients from two referral academic center were enrolled in the study

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Kidney recipients older than 18 years of age
* Patients receiving a kidney transplant from a living or brain-dead donor

Exclusion Criteria

* Patients who have received a previous transplant with an organ other than the kidney
* Patients without available graft biopsy material for molecular HistoMx testing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paris Translational Research Center for Organ Transplantation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Lefaucheur

Role: PRINCIPAL_INVESTIGATOR

Paris Translational Research Center for Organ Transplantation

Alexandre Loupy

Role: PRINCIPAL_INVESTIGATOR

Paris Translational Research Center for Organ Transplantation

Locations

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Paris Bichat university hospital

Paris, , France

Site Status

Paris Saint Louis University hospital

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 39081730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40345499 (View on PubMed)

Other Identifiers

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Molecular_kidney rejection

Identifier Type: -

Identifier Source: org_study_id

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