Status:
COMPLETED
Mass Spectrometry-based Proteomics in Microvascular Inflammation Diagnosis in Kidney Transplantation.
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Kidney Transplantation
Graft Rejection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Microvascular inflammation, the hallmark histological criteria of antibody-mediated rejection in kidney transplantation, remains an issue in routine practice, due to a lack of reproducibility in its r...
Detailed Description
Antibody-mediated rejection (ABMR) is due to pathogenic antibodies produced by the donor (donor-specific antibodies, DSA) that are directed against Human Leukocyte Antigens (HLA) or other antigens (no...
Eligibility Criteria
Inclusion
- Kidney transplant recipients
- Diagnosis based on the 2019 Banff classification (polyomavirus nephropathy, T cell-mediated rejection, borderline changes)
- Renal allograft biopsy allowing inclusion with at least 7 permeable glomeruli
- The microvascular inflammation group with anti-HLA DSA is defined as follows:
- At least moderate microvascular inflammation: g + ptc \> 2
- At least one anti-HLA DSA in the serum at the time of biopsy, with a Mean Fluorescence Intensity (MFI) \> 3000 for the immunodominant DSA or the sum of the DSA
- The microvascular inflammation group without anti-HLA DSA is defined as follows:
- At least moderate microvascular inflammation: g + ptc \> 2
- No historical anti-HLA DSA or at the time of biopsy, MFI \< 500
- The stable graft recipients group is defined as follows:
- Glomerual Filtration Rate \> 40ml/min, without clinical proteinuria
- No detectable DSA
- Protocol biopsy at 1 year posttransplantation without specific lesion or nonspecific severe lesion
- The chronic nonspecific graft changes group is defined as follows:
- Moderate to severe interstitial fibrosis and tubular atrophy, in the absence of specific lesions: active rejection (antibody-mediated or T cell-mediated), borderline lesions, recurrent or de novo nephropathy, polyomavirus associated nephropathy.
- No C4d deposits on peritubular capillaries
- No detectable anti-HLA DSA at the time of biopsy.
- The ischemic acute tubular injuries group is defined as :
- Histological lesions of tubular injuries in the absence of significant microvascular inflammation or C4d deposits
- No detectable anti-HLA DSA at the time of biopsy
Exclusion
- Minor patients
- Mixed rejection (antibody-mediated and T cell-mediated)
- Recurrent or de novo nephropathy
- Specific treatment of rejection (T cell-mediated or antibody-mediated) in the last 6 months, excluding induction and
- Baseline immunosuppressive treatment.
Key Trial Info
Start Date :
November 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2024
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04851145
Start Date
November 8 2021
End Date
May 5 2024
Last Update
December 24 2024
Active Locations (3)
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1
Hôpital Pellegrin
Bordeaux, France, 33000
2
Hôpital Edouard Herriot
Lyon, France, 69003
3
Hôpital Necker
Paris, France, 75015