Graft RejectionNCT07347353
Molecular HistoMx Assessment for Kidney Transplant Rejection and Management
An observational study of Graft Rejection, run by Paris Translational Research Center for Organ Transplantation at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Rejection
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Feb 2020to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Kidney transplant recipients from two French referral centers
Who may be able to join
- Kidney recipients older than 18 years of age
- Patients receiving a kidney transplant from a living or brain-dead donor
Who cannot join
- Patients who have received a previous transplant with an organ other than the kidney
- Patients without available graft biopsy material for molecular HistoMx testing
Trial locations and contacts
2 sites in 1 country.
France2 sites
Paris Bichat university hospital
Paris
Paris Saint Louis University hospital
Paris
About this study
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.
- Conditions
- Graft Rejection
- Being tested
- No intervention
- Keywords
- molecular diagnosis, kidney transplantation, graft rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients from two referral academic center were enrolled in the study | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice
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
Measured: 12 months
Secondary outcomes (1)
Graft function at 12 months after graft biopsy
The secondary objectives are to graft function at 12 months after graft biopsy using estimated Glomerular Filtration Rate (eGFR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Feb 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Graft RejectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Lefaucheur, Principal investigator, Paris Translational Research Center for Organ TransplantationAlexandre Loupy, Principal investigator, Paris Translational Research Center for Organ Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347353
- Sponsor's protocol ID
- Molecular_kidney rejection
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giarraputo A, Goutaudier V, Robin B, Angelini A, Sablik M, Aubert O, Rosales IA, Smith RN, Roufosse C, Adam B, Haas M, Colvin RB, Lefaucheur C, Mengel M, Zielinski D, Loupy A. Relevance of the Banff Human Organ Transplant Consensus Gene Panel for Detecting Antibody and T-Cell-Mediated Rejection of Kidney Allografts. Kidney Int Rep. 2024 May 4;9(7):2290-2294. doi: 10.1016/j.ekir.2024.04.054. eCollection 2024 Jul. No abstract available.
PubMed 39081730Zielinski D, Goutaudier V, Sablik M, Divard G, Aubert O, Piedrafita A, Mezine F, Dagobert J, Certain A, Robin B, Gueguen J, Rabant M, Duong van Huyen JP, Sannier A, Randoux-Lebrun C, Maanaoui M, Lionet A, Gibier JB, Gnemmi V, Le Quintrec M, Chauveau B, Vermorel A, Couzi L, Bestard O, Elias M, Louis K, Rosales IA, Smith RN, Kung VL, Anglicheau D, Legendre C, Del Bello A, Huang E, Adam B, Kamar N, Colvin RB, Mengel M, Lefaucheur C, Loupy A. Molecular diagnosis of kidney allograft rejection based on the Banff Human Organ Transplant gene panel: A multicenter international study. Am J Transplant. 2025 Aug;25(8):1631-1642. doi: 10.1016/j.ajt.2025.04.025. Epub 2025 May 8.
PubMed 40345499
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular HistoMx Assessment for Kidney Transplant Rejection and Management
- ClinicalTrials.gov ID
- NCT07347353
- Acronym / sponsor ID
- Molecular_kidney rejection
- Conditions
- Graft Rejection
- Keywords
- molecular diagnosis, kidney transplantation, graft rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Jan 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients from two referral academic center were enrolled in the study | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients from two French referral centers
Key inclusion criteria (2 listed)
- Kidney recipients older than 18 years of age
- Patients receiving a kidney transplant from a living or brain-dead donor
Key exclusion criteria (2 listed)
- Patients who have received a previous transplant with an organ other than the kidney
- Patients without available graft biopsy material for molecular HistoMx testing
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 |
|---|---|---|
| No interventionNo intervention | Other | Kidney transplant recipients from two referral academic center were enrolled in the study |
Primary outcome
Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice
Time frame: 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
1 secondary outcome
Graft function at 12 months after graft biopsy
Time frame: 12 months
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 16 Jan 2026.
- Background: PubMed 39081730Giarraputo A, Goutaudier V, Robin B, Angelini A, Sablik M, Aubert O, Rosales IA, Smith RN, Roufosse C, Adam B, Haas M, Colvin RB, Lefaucheur C, Mengel M, Zielinski D, Loupy A. Relevance of the Banff Human Organ Transplant Consensus Gene Panel for Detecting Antibody and T-Cell-Mediated Rejection of Kidney Allografts. Kidney Int Rep. 2024 May 4;9(7):2290-2294. doi: 10.1016/j.ekir.2024.04.054. eCollection 2024 Jul. No abstract available.
- Background: PubMed 40345499Zielinski D, Goutaudier V, Sablik M, Divard G, Aubert O, Piedrafita A, Mezine F, Dagobert J, Certain A, Robin B, Gueguen J, Rabant M, Duong van Huyen JP, Sannier A, Randoux-Lebrun C, Maanaoui M, Lionet A, Gibier JB, Gnemmi V, Le Quintrec M, Chauveau B, Vermorel A, Couzi L, Bestard O, Elias M, Louis K, Rosales IA, Smith RN, Kung VL, Anglicheau D, Legendre C, Del Bello A, Huang E, Adam B, Kamar N, Colvin RB, Mengel M, Lefaucheur C, Loupy A. Molecular diagnosis of kidney allograft rejection based on the Banff Human Organ Transplant gene panel: A multicenter international study. Am J Transplant. 2025 Aug;25(8):1631-1642. doi: 10.1016/j.ajt.2025.04.025. Epub 2025 May 8.
- 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.
Carmen Lefaucheur principal investigator
Paris Translational Research Center for Organ Transplantation
Alexandre Loupy principal investigator
Paris Translational Research Center for Organ Transplantation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Rejection, run by Paris Translational Research Center for Organ Transplantation at 2 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 2 inclusion and 2 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07347353, which also lists 2 linked publications.
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 16 Jan 2026.