Kidney TransplantationTranSpecNCT04851145
Mass Spectrometry-based Proteomics in Microvascular Inflammation Diagnosis in Kidney Transplantation.
A study testing Mass spectrometry-based proteomics of FFPE biopsies and urine samples in people with Kidney Transplantation and Graft Rejection, run by University Hospital, Bordeaux at 3 sites in France.
Trial 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 recognition by pathologists and an incomplete comprehension of its pathophysiology, leading to a poor treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Graft Rejection, Humoral Immunity
- What is being tested?
- Mass spectrometry-based proteomics of FFPE biopsies and urine samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Nov 2021to 5 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Pellegrin
Bordeaux, 33000
Hôpital Edouard Herriot
Lyon, 69003
Hôpital Necker
Paris, 75015
About this study
Official title: Diagnostic Value of Mass Spectrometry-based Proteomics in Microvascular Inflammation in Kidney Transplantation, the TranSpec Study.
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 recognition by pathologists and an incomplete comprehension of its pathophysiology, leading to a poor treatment efficacy. The main objective of this study is to assess the performances of tissue proteic signatures designed for the diagnosis of microvascular inflammation in kidney transplantation, from formalin-fixed and paraffin-embedded (FFPE) allograft biopsies analyzed by mass spectrometry-based proteomics.
Read the 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 (non HLA) of the graft. ABMR is currently the leading cause of long-term kidney allograft failure. Histological lesions of microvascular inflammation (MVI) are the hallmark criteria of ABMR according to the 2019 Banff classification. Lack of reproducibility in the scoring of MVI by pathologists is still an issue of the diagnosis of ABMR in routine practice, while the understood pathophysiological mechanisms of MVI (anti-HLA DSA, DSA against non HLA antigens and/or NK cell-mediated) are poorly assessed in practice, possibly explaining the wide variability of treatment efficacy. In a prior study, the investigators confirmed the value of mass spectrometry for the analysis of the glomerular proteome during ABMR, compared to the one of stable grafts, from FFPE biopsies. The investigators identified 82 proteins, particularly involved in leukocyte activation and the interferons pathways, in accordance with transcriptomic approaches. Five proteins were validated by immunohistochemistry.
The investigators now propose to analyze kidney allograft FFPE biopsies of 92 patients by mass spectrometry, including 32 with MVI (with and without anti-HLA DSA) and 60 with relevant differential diagnoses. The main objective is to assess the diagnostic performances of tissue proteic signatures designed by machine-learning methods for the diagnosis of microvascular inflammation, the reference standard being the 2019 Banff classification. One of the secondary objectives includes the comparison of the protein profile of MVI with and without anti-HLA DSA, but also the proteomic analysis of 60 urine samples from the same population, in order to assess the performances of mass spectrometry in the non-invasive diagnosis of MVI in kidney transplantation.
- Conditions
- Kidney Transplantation, Graft Rejection, Humoral Immunity, Proteomics
- Being tested
- Mass spectrometry-based proteomics of FFPE biopsies and urine samples
- Keywords
- Antibody-mediated rejection, microvascular inflammation, proteomics, kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mass spectrometry-based proteomics of FFPE biopsies and urine samplesDiagnostic test
The biopsy and urine samples will be processed by the OncoProt platform (University of Bordeaux) for proteomic analysis by tandem mass spectrometry (label-free quantification) as follows:
- Biopsies: laser microdissection of the renal cortex, fixation reversion, protein extraction and electrophoretic migration, tryptic digestion.
- Urines: samples concentration by centrifugation/filtration and tryptic digestion according to a protocol adapted from the FASP method (Filter-Aided Sample Preparation)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Diagnostic Test: Mass spectrometry-based proteomics of FFPE biopsies and urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing diagnostic performance of tissue protein signature
The primary outcome is the sensitivity and specificity of tissue protein signature in the diagnosis of microvascular inflammation (MVI) in kidney transplantation, the diagnostic reference standard being based on the 2019 Banff classification (histological and biological criteria). This primary outcome is based on FFPE kidney allograft biopsies.
Measured: 18 months after inclusion
Secondary outcomes (4)
Assessing the diagnostic performance of urine protein signatures
Sensitivity and specificity of the urinary protein signature in the diagnosis of MVI in kidney transplantation, compared to the reference standard (2019 Banff classification)
Measured: 18 months after inclusion
Assessing the performance of tissue proteomic signature
Sensitivity and specificity of tissue proteomic analysis in the prediction of the MVI subtype (anti-HLA DSA or not)
Measured: 18 months after inclusion
Assessing the performance of urine proteomic signature
Sensitivity and specificity of urine proteomic analysis in the prediction of the MVI subtype (anti-HLA DSA or not)
Measured: 18 months after inclusion
Compare protein profiles observed within different phenotypes of MVI in kidney transplantation
To describe and compare protein profiles observed within different phenotypes of MVI in kidney transplantation, at tissue and urine protein level according to Banff 2019 (with and without anti-HLA DSA).
Measured: 18 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start8 Nov 2021
- Primary completion5 May 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851145
- Sponsor's protocol ID
- CHUBX 2020/47
- Other IDs
- 2021-A00288-33
- Acronym
- TranSpec
- Status last verified
- Dec 2024
- First submitted
- 14 Apr 2021
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Mass Spectrometry-based Proteomics in Microvascular Inflammation in Kidney Transplantation, the TranSpec Study.
- ClinicalTrials.gov ID
- NCT04851145
- Acronym / sponsor ID
- TranSpec / CHUBX 2020/47
- Conditions
- Kidney Transplantation, Graft Rejection, Humoral Immunity, Proteomics
- Keywords
- Antibody-mediated rejection, microvascular inflammation, proteomics, kidney transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 recognition by pathologists and an incomplete comprehension of its pathophysiology, leading to a poor treatment efficacy. The main objective of this study is to assess the performances of tissue proteic signatures designed for the diagnosis of microvascular inflammation in kidney transplantation, from formalin-fixed and paraffin-embedded (FFPE) allograft biopsies analyzed by mass spectrometry-based proteomics.
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 (non HLA) of the graft. ABMR is currently the leading cause of long-term kidney allograft failure. Histological lesions of microvascular inflammation (MVI) are the hallmark criteria of ABMR according to the 2019 Banff classification. Lack of reproducibility in the scoring of MVI by pathologists is still an issue of the diagnosis of ABMR in routine practice, while the understood pathophysiological mechanisms of MVI (anti-HLA DSA, DSA against non HLA antigens and/or NK cell-mediated) are poorly assessed in practice, possibly explaining the wide variability of treatment efficacy. In a prior study, the investigators confirmed the value of mass spectrometry for the analysis of the glomerular proteome during ABMR, compared to the one of stable grafts, from FFPE biopsies. The investigators identified 82 proteins, particularly involved in leukocyte activation and the interferons pathways, in accordance with transcriptomic approaches. Five proteins were validated by immunohistochemistry.
The investigators now propose to analyze kidney allograft FFPE biopsies of 92 patients by mass spectrometry, including 32 with MVI (with and without anti-HLA DSA) and 60 with relevant differential diagnoses. The main objective is to assess the diagnostic performances of tissue proteic signatures designed by machine-learning methods for the diagnosis of microvascular inflammation, the reference standard being the 2019 Banff classification. One of the secondary objectives includes the comparison of the protein profile of MVI with and without anti-HLA DSA, but also the proteomic analysis of 60 urine samples from the same population, in order to assess the performances of mass spectrometry in the non-invasive diagnosis of MVI in kidney transplantation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Mass spectrometry-based proteomics of FFPE biopsies and urine samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- The microvascular inflammation group without anti-HLA DSA is defined as follows:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mass spectrometry-based proteomics of FFPE biopsies and urine samplesThe biopsy and urine samples will be processed by the OncoProt platform (University of Bordeaux) for proteomic analysis by tandem mass spectrometry (label-free quantification) as follows: * Biopsies: laser microdissection of the renal cortex, fixation reversion, protein extraction and electrophoretic migration, tryptic digestion. * Urines: samples concentration by centrifugation/filtration and tryptic digestion according to a protocol adapted from the FASP method (Filter-Aided Sample Preparation) | Diagnostic test | Experimental |
Primary outcome
Assessing diagnostic performance of tissue protein signature
Time frame: 18 months after inclusion
The primary outcome is the sensitivity and specificity of tissue protein signature in the diagnosis of microvascular inflammation (MVI) in kidney transplantation, the diagnostic reference standard being based on the 2019 Banff classification (histological and biological criteria). This primary outcome is based on FFPE kidney allograft biopsies.
4 secondary outcomes
Assessing the diagnostic performance of urine protein signatures
Time frame: 18 months after inclusion
Assessing the performance of tissue proteomic signature
Time frame: 18 months after inclusion
Assessing the performance of urine proteomic signature
Time frame: 18 months after inclusion
Compare protein profiles observed within different phenotypes of MVI in kidney transplantation
Time frame: 18 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mass spectrometry-based proteomics of FFPE biopsies and urine samples in people with Kidney Transplantation and Graft Rejection, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing diagnostic performance of tissue protein signature (time frame: 18 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.