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Completed

NCT Number: NCT07347353

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.

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Key information

Conditions

Graft Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris Bichat university hospital, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice

    Time frame: 12 months

    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

Secondary outcomes

  1. Graft function at 12 months after graft biopsy

    Time frame: 12 months

    The secondary objectives are to graft function at 12 months after graft biopsy using estimated Glomerular Filtration Rate (eGFR)

Other outcomes

  1. Probability of graft survival after graft biopsy

    Time frame: 12 months

    The objective is to measure probability of graft survival post graft biopsy using the iBox predictive system

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

    Time frame: 12 months

    The objective is to measure the rate of participants with diagnosis of graft rejection based on molecular assessment

  3. Rate of participants with therapeutic changes based on graft rejection diagnosis

    Time frame: 12 months

    The objective is to measure rate of participants with therapeutic changes based on graft rejection diagnosis

Sponsors and collaborators

Lead sponsor

Paris Translational Research Center for Organ Transplantation

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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