Mass Spectrometry-based Proteomics in Microvascular Inflammation Diagnosis in Kidney Transplantat… (NCT04851145) | Clinical Trial Compass
CompletedNot Applicable
Mass Spectrometry-based Proteomics in Microvascular Inflammation Diagnosis in Kidney Transplantation.
France141 participantsStarted 2021-11-08
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 grou…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessing diagnostic performance of tissue protein signature