Graft Rejection
Conditions
Keywords
molecular diagnosis, kidney transplantation, graft rejection
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Paris Translational Research Center for Organ Transplantation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice | 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
| Measure | Time frame | Description |
|---|---|---|
| Graft function at 12 months after graft biopsy | 12 months | The secondary objectives are to graft function at 12 months after graft biopsy using estimated Glomerular Filtration Rate (eGFR) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Probability of graft survival after graft biopsy | 12 months | The objective is to measure probability of graft survival post graft biopsy using the iBox predictive system |
| Rate of participants with graft rejection diagnosis based on molecular assessment of graft biopsy | 12 months | The objective is to measure the rate of participants with diagnosis of graft rejection based on molecular assessment |
| Rate of participants with therapeutic changes based on graft rejection diagnosis | 12 months | The objective is to measure rate of participants with therapeutic changes based on graft rejection diagnosis |
Countries
France
Outcome results
None listed