Molecular HistoMx Assessment for Kidney Transplant Rejection and Management

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.

Study Overview

• Status: Completed
• Conditions: Graft Rejection
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Paris Bichat university hospital
  • Paris, France
    • Paris Saint Louis University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients from two French referral centers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kidney transplant recipients from two referral academic center were enrolled in the study	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Paris Translational Research Center for Organ Transplantation
• Investigators: Principal Investigator: Carmen Lefaucheur, Paris Translational Research Center for Organ Transplantation; Principal Investigator: Alexandre Loupy, Paris Translational Research Center for Organ Transplantation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: kidney transplantation; molecular diagnosis; graft rejection
• Other Study ID Numbers: Molecular_kidney rejection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No