Molecular HistoMx Assessment for Kidney Transplant Rejection and Management

Paris Translational Research Center for Organ Transplantation

Status: Completed

Conditions: Graft Rejection

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07347353

Molecular_kidney rejection

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

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

Treatment:

Other: No intervention