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Molecular HistoMx Assessment for Kidney Transplant Rejection and Management

NCT07347353 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-01-16

No results posted yet for this study

Summary

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.

Conditions

  • Graft Rejection

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • Paris Translational Research Center for Organ Transplantation

    lead OTHER

Principal Investigators

  • Carmen Lefaucheur · Paris Translational Research Center for Organ Transplantation

  • Alexandre Loupy · Paris Translational Research Center for Organ Transplantation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07347353 on ClinicalTrials.gov