Protein fingerprints may spot hidden transplant rejection
NCT ID NCT04851145
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether analyzing proteins from kidney biopsy and urine samples can improve the diagnosis of microvascular inflammation, a key sign of antibody-mediated rejection in kidney transplant recipients. Researchers used mass spectrometry to find protein signatures in 141 patients and compared results to standard diagnostic criteria. The goal is to make rejection diagnosis more consistent and accurate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mass spectrometry-based proteomics (protein analysis of biopsy and urine samples)
- What this could lead to
- If successful, this could lead to a more accurate and reliable way to diagnose antibody-mediated rejection in kidney transplants, helping doctors treat it earlier.
- What could go wrong
- This is a completed diagnostic study, not a treatment trial. The protein signatures may not prove accurate enough in larger, diverse groups, and the method is complex and not yet ready for routine use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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141 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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May 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Edouard Herriot
Lyon, 69003, France
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Hôpital Necker
Paris, 75015, France
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Hôpital Pellegrin
Bordeaux, 33000, France
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