Molecular HistoMx Assessment for Kidney Transplant Rejection and Management

NCT07347353 | Completed

• 1 other identifier: Molecular_kidney rejection
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

molecular diagnosis; kidney transplantation; graft rejection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Graft function at 12 months after graft biopsy

  12 months

Other Outcomes (3)

• Probability of graft survival after graft biopsy

  12 months

• Rate of participants with graft rejection diagnosis based on molecular assessment of graft biopsy

  12 months

• Rate of participants with therapeutic changes based on graft rejection diagnosis

  12 months

Study Arms (1)

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

Other: No intervention

Interventions

No intervention OTHER

No intervention

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients from two French referral centers

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (2)

Paris Bichat university hospital

Paris, France

Location

Paris Saint Louis University hospital

Paris, France

Location

Related Publications (2)

• 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.

  PMID: 39081730 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.

  PMID: 40345499 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

kidney graft biopsy

Study Officials

• Carmen Lefaucheur

  Paris Translational Research Center for Organ Transplantation

  PRINCIPAL INVESTIGATOR

• Alexandre Loupy

  Paris Translational Research Center for Organ Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 16, 2026
• Study Start: February 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)