Kidney TransplantationKTD-innovNCT03582436
Rejection Diagnosis in Kidney Transplants Patients
An observational study of Kidney Transplantation and Transplant Rejection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Main objective: To constitute a prospective multicentre French cohort of kidney transplant recipients including clinical, biological and immunological evaluation combined with non-invasive biomarkers in peripheral blood and urine, and gene expression assessment in allograft biopsy in order to increase the performance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Transplant Rejection, Graft Survival
- What is being tested?
- Kidney transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 824 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2018to 18 Mar 2021
- 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: New kidney transplants patients
Who may be able to join
- Men or female patients, Age ≥ 18 years old at the time of transplantation. Patients receiving a kidney transplant from a living or deceased donor. Patients who signed the informed consent form and willing to comply with study procedures.
- Female patients of child-bearing potential must have a negative pregnancy test (serum beta-hCG) and must be practicing an effective, reliable and medically approved contraceptive regimen
- Patients with a minimum weight of 40 kg
Who cannot join
- History of multi-organ transplant (interference with rejection natural history).
- Unable/unwilling to comply with study procedures (including foreign language speakers who are not assisted by a native French speaker).
- Vulnerable participants (minors, protected adults, pregnant women, legally detained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective KTD-innov Cohort of Kidney Transplants Patients
Main objective: To constitute a prospective multicentre French cohort of kidney transplant recipients including clinical, biological and immunological evaluation combined with non-invasive biomarkers in peripheral blood and urine, and gene expression assessment in allograft biopsy in order to increase the performance of rejection diagnosis in kidney transplant patients.
the investigators hypothesise that the addition of non-invasive biomarkers and intragraft assessment of gene expression profiles will improve the diagnosis capacity of histology in kidney transplant recipients as it reveals pathophysiological pathways that are not captured by light microscopy.
Read the detailed description
Rejection currently represents the major cause of allograft failure worldwide, with immediate consequences for the patients in terms of mortality, morbidity and costs for the society. The field of transplantation lacks robust assessments for immune monitoring and diagnoses. Currently, light microscopy still represents the gold standard, which has clearly been identified as imperfect. Given those facts, success of clinical trials is impaired with space for improvement of current diagnosis standards that should eventually lead to improved outcomes for kidney transplant recipients.
This study will provide the investigators with prospective data of kidney transplant patient that will allow the improvement of rejection diagnosis and individual immune monitoring for precision medicine: improvement of rejection diagnosis, stage and assessment of response to therapy. In order to estimate for each patient a probability of rejection, The investigators will generate algorithms using traditional clinical, biological and histological data that will be enriched by tissue as well as blood and urine non-invasive immune biomarkers.
These algorithms will be encapsulated in a "user-friendly" web-based application with best in-class visualisation : the TransplanScreen will display individual information with comparative and predictive context for clinicians and patients and better interfacing and communication. It will include a comprehensive TransplanScreen report based on the algorithms and included in Electronic Medical Record databases (object-oriented). It aims to provide visual and contextual information to promote personalised decision making, addressing the demand of public health authorities for improving efficiency and quality of care.
The expected benefit for participants and society will be to reduce the financial burden of graft rejection for society.
The cohort will include n=750 kidney transplant recipients in 8 French centres : 3 Parisian ones: Necker hospital, Saint-Louis Hospital and Bichat hospital and 4 regional ones: CHU Nantes, Toulouse and Bordeaux, Montpellier and Lyon Hospitals. Bichat hospital will not be recruiting but will contribute to the research.
Vulnerable participants excluded.
Schedule for the study:
- inclusion period: 12 months
- participation period (treatment - follow-up): 12 months
- total duration of the study: 24 months
Exclusion period for participation in other studies, and justification: the participation to other minimal risks and constraints studies and observational non-interventional studies is allowed during this study. There is no exclusion period at the end of study. The participation to other interventional and observational non-interventional studies is allowed after the end of the study.
Number of enrolments expected per site and per month :
- Necker Hospital: 14 patients / month
- Saint-Louis Hospital: 8 patients / month
- CHU Nantes: 10 patients / month
- Lyon Hospitals: 9 patients / month
- CHU Toulouse: 13 patients / month
- CHU Bordeaux: 9 patients / month.
- CHU Montpelier: 8/month
- Conditions
- Kidney Transplantation, Transplant Rejection, Graft Survival
- Being tested
- Kidney transplantation
- Keywords
- Kidney, Allogeneic transplantation, Cohort study, Rejection, Biomarkers, Integrative medicine
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney transplantationProcedure or surgery
Also called Transcriptomics analysis, Non-HLA antibodies analysis, Omics blood analysis, Urine chemokines analysis,
For the patients with the kidney transplantation, these parameters will be analysis:
Transcriptomics analysis Characteristics of anti HLA DSA analysis Non-HLA antibodies analysis Omics blood analysis Urine chemokines analysis
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Kidney transplantation Receives: Procedure: Kidney transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of invasive/non-invasive biomarkers with allograft rejection
Concordance of invasive/non-invasive biomarkers with allograft rejection diagnosed by the gold standard (histology) in kidney transplant recipients.
Measured: month 12
Secondary outcomes (13)
Association of non-invasive biomarkers with different subtypes of rejection
Association of non-invasive biomarkers with different subtypes of rejection
Measured: month 12
Association of gene sets with different subtypes of rejection in the biopsy.
Association of gene sets with different subtypes of rejection in the biopsy.
Measured: month 12
Reclassification capacity of gene sets and non-invasive biomarkers to define allograft rejection.
Reclassification capacity of gene sets and non-invasive biomarkers to define allograft rejection
Measured: month 12
Variation of the non-invasive biomarker signature of allograft rejection
ariation of the non-invasive biomarker signature of allograft rejection as a response to the standard of care in kidney transplant recipients.
Measured: month 12
Variation of the gene set signature
Variation of the gene set signature of allograft rejection from the biopsy as a response to the standard of care in kidney transplant recipients.
Measured: month 12
Cumulative incidence of antibody-mediated rejection (ABMR)
Cumulative incidence of antibody-mediated rejection (ABMR) that occurs between D0 and M12 (ABMR that meets Banff 2015 criteria)
Measured: month 12
Cumulative incidence of T-cell-mediated rejection (TCMR)
Cumulative incidence of T-cell-mediated rejection (TCMR) that occurs between D0 and M12 (TCMR that meets Banff 2015 criteria)
Measured: month 12
Treatment failure rate
Treatment failure rate defined as the occurrence of 1) biopsy proven ABMR and/or TCMR, 2) graft loss, 3) patient death
Measured: month 12
Graft and patient survival
Graft and patient survival at M6 and M12 post-transplantation
Measured: month 12
Histological evidence of ABMR and/or TCMR on protocol biopsies
Histological evidence of ABMR and/or TCMR on protocol biopsies without other clinical findings at M3 and M12 post-transplantation
Measured: month 12
Overall pathological changes, including chronic ABMR
Overall pathological changes, including chronic ABMR, on protocol biopsies M3 and M12 post-transplantation
Measured: month 12
Incidence of delayed graft function
Incidence of delayed graft function (DGF) post-transplantation
Measured: month 12
Cumulative incidence and duration of dialysis.
Cumulative incidence and duration of dialysis between 7 days and M12 post- transplantation
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start25 Jun 2018
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
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 Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Loupy, Pr, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582436
- Sponsor's protocol ID
- K170909J
- Other IDs
- 2018-A00090-55
- Acronym
- KTD-innov
- Status last verified
- Feb 2022
- First submitted
- 25 Jun 2018
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goutaudier V, Aubert O, Racape M, Truchot A, Sablik M, Raynaud M, Vicaut E, Rousseau O, Elias M, Divard G, Papuchon E, Danger R, Charreau B, Bouton D, Nguyen-Khoa T, Randoux-Lebrun C, Taupin JL, Gourraud PA, Giral M, Le Quintrec M, Morelon E, Couzi L, Legendre C, Lefaucheur C, Kamar N, Brouard S, Anglicheau D, Loupy A; KTD-Innov Consortium. Detection of Kidney Allograft Rejection Using Urinary Chemokines. J Am Soc Nephrol. 2025 Nov 1;36(11):2228-2240. doi: 10.1681/ASN.0000000742. Epub 2025 Jun 12.
PubMed 40504617Goutaudier V, Sablik M, Racape M, Rousseau O, Audry B, Kamar N, Raynaud M, Aubert O, Charreau B, Papuchon E, Danger R, Letertre L, Couzi L, Morelon E, Le Quintrec M, Taupin JL, Vicaut E, Legendre C, Le Mai H, Potluri V, Nguyen TV, Azoury ME, Pinheiro A, Nouadje G, Sonigo P, Anglicheau D, Tieken I, Vogelaar S, Jacquelinet C, Reese P, Gourraud PA, Brouard S, Lefaucheur C, Loupy A; KTD-Innov Consortium. Design, cohort profile and comparison of the KTD-Innov study: a prospective multidimensional biomarker validation study in kidney allograft rejection. Eur J Epidemiol. 2024 May;39(5):549-564. doi: 10.1007/s10654-024-01112-w. Epub 2024 Apr 16.
PubMed 38625480
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective KTD-innov Cohort of Kidney Transplants Patients
- ClinicalTrials.gov ID
- NCT03582436
- Acronym / sponsor ID
- KTD-innov / K170909J
- Conditions
- Kidney Transplantation, Transplant Rejection, Graft Survival
- Keywords
- Kidney, Allogeneic transplantation, Cohort study, Rejection, Biomarkers, Integrative medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 11 Jul 2018 (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.
Main objective: To constitute a prospective multicentre French cohort of kidney transplant recipients including clinical, biological and immunological evaluation combined with non-invasive biomarkers in peripheral blood and urine, and gene expression assessment in allograft biopsy in order to increase the performance of rejection diagnosis in kidney transplant patients.
the investigators hypothesise that the addition of non-invasive biomarkers and intragraft assessment of gene expression profiles will improve the diagnosis capacity of histology in kidney transplant recipients as it reveals pathophysiological pathways that are not captured by light microscopy.
Detailed description
Rejection currently represents the major cause of allograft failure worldwide, with immediate consequences for the patients in terms of mortality, morbidity and costs for the society. The field of transplantation lacks robust assessments for immune monitoring and diagnoses. Currently, light microscopy still represents the gold standard, which has clearly been identified as imperfect. Given those facts, success of clinical trials is impaired with space for improvement of current diagnosis standards that should eventually lead to improved outcomes for kidney transplant recipients.
This study will provide the investigators with prospective data of kidney transplant patient that will allow the improvement of rejection diagnosis and individual immune monitoring for precision medicine: improvement of rejection diagnosis, stage and assessment of response to therapy. In order to estimate for each patient a probability of rejection, The investigators will generate algorithms using traditional clinical, biological and histological data that will be enriched by tissue as well as blood and urine non-invasive immune biomarkers.
These algorithms will be encapsulated in a "user-friendly" web-based application with best in-class visualisation : the TransplanScreen will display individual information with comparative and predictive context for clinicians and patients and better interfacing and communication. It will include a comprehensive TransplanScreen report based on the algorithms and included in Electronic Medical Record databases (object-oriented). It aims to provide visual and contextual information to promote personalised decision making, addressing the demand of public health authorities for improving efficiency and quality of care.
The expected benefit for participants and society will be to reduce the financial burden of graft rejection for society.
The cohort will include n=750 kidney transplant recipients in 8 French centres : 3 Parisian ones: Necker hospital, Saint-Louis Hospital and Bichat hospital and 4 regional ones: CHU Nantes, Toulouse and Bordeaux, Montpellier and Lyon Hospitals. Bichat hospital will not be recruiting but will contribute to the research.
Vulnerable participants excluded.
Schedule for the study:
- inclusion period: 12 months
- participation period (treatment - follow-up): 12 months
- total duration of the study: 24 months
Exclusion period for participation in other studies, and justification: the participation to other minimal risks and constraints studies and observational non-interventional studies is allowed during this study. There is no exclusion period at the end of study. The participation to other interventional and observational non-interventional studies is allowed after the end of the study.
Number of enrolments expected per site and per month :
- Necker Hospital: 14 patients / month
- Saint-Louis Hospital: 8 patients / month
- CHU Nantes: 10 patients / month
- Lyon Hospitals: 9 patients / month
- CHU Toulouse: 13 patients / month
- CHU Bordeaux: 9 patients / month.
- CHU Montpelier: 8/month
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Procedure: Kidney transplantationKidney transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New kidney transplants patients
Key inclusion criteria (3 listed)
- Men or female patients, Age ≥ 18 years old at the time of transplantation. Patients receiving a kidney transplant from a living or deceased donor. Patients who signed the informed consent form and willing to comply with study procedures.
- Female patients of child-bearing potential must have a negative pregnancy test (serum beta-hCG) and must be practicing an effective, reliable and medically approved contraceptive regimen
- Patients with a minimum weight of 40 kg
Key exclusion criteria (3 listed)
- History of multi-organ transplant (interference with rejection natural history).
- Unable/unwilling to comply with study procedures (including foreign language speakers who are not assisted by a native French speaker).
- Vulnerable participants (minors, protected adults, pregnant women, legally detained
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 |
|---|---|---|
| Kidney transplantationAlso: Transcriptomics analysis, Non-HLA antibodies analysis, Omics blood analysis, Urine chemokines analysis,For the patients with the kidney transplantation, these parameters will be analysis: Transcriptomics analysis Characteristics of anti HLA DSA analysis Non-HLA antibodies analysis Omics blood analysis Urine chemokines analysis | Procedure or surgery | Prospective cohort |
Primary outcome
Concordance of invasive/non-invasive biomarkers with allograft rejection
Time frame: month 12
Concordance of invasive/non-invasive biomarkers with allograft rejection diagnosed by the gold standard (histology) in kidney transplant recipients.
13 secondary outcomes
Association of non-invasive biomarkers with different subtypes of rejection
Time frame: month 12
Association of gene sets with different subtypes of rejection in the biopsy.
Time frame: month 12
Reclassification capacity of gene sets and non-invasive biomarkers to define allograft rejection.
Time frame: month 12
Variation of the non-invasive biomarker signature of allograft rejection
Time frame: month 12
Variation of the gene set signature
Time frame: month 12
Cumulative incidence of antibody-mediated rejection (ABMR)
Time frame: month 12
Cumulative incidence of T-cell-mediated rejection (TCMR)
Time frame: month 12
Treatment failure rate
Time frame: month 12
Graft and patient survival
Time frame: month 12
Histological evidence of ABMR and/or TCMR on protocol biopsies
Time frame: month 12
Overall pathological changes, including chronic ABMR
Time frame: month 12
Incidence of delayed graft function
Time frame: month 12
Cumulative incidence and duration of dialysis.
Time frame: month 12
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 10 Feb 2022.
- Derived from this study: PubMed 40504617Goutaudier V, Aubert O, Racape M, Truchot A, Sablik M, Raynaud M, Vicaut E, Rousseau O, Elias M, Divard G, Papuchon E, Danger R, Charreau B, Bouton D, Nguyen-Khoa T, Randoux-Lebrun C, Taupin JL, Gourraud PA, Giral M, Le Quintrec M, Morelon E, Couzi L, Legendre C, Lefaucheur C, Kamar N, Brouard S, Anglicheau D, Loupy A; KTD-Innov Consortium. Detection of Kidney Allograft Rejection Using Urinary Chemokines. J Am Soc Nephrol. 2025 Nov 1;36(11):2228-2240. doi: 10.1681/ASN.0000000742. Epub 2025 Jun 12.
- Derived from this study: PubMed 38625480Goutaudier V, Sablik M, Racape M, Rousseau O, Audry B, Kamar N, Raynaud M, Aubert O, Charreau B, Papuchon E, Danger R, Letertre L, Couzi L, Morelon E, Le Quintrec M, Taupin JL, Vicaut E, Legendre C, Le Mai H, Potluri V, Nguyen TV, Azoury ME, Pinheiro A, Nouadje G, Sonigo P, Anglicheau D, Tieken I, Vogelaar S, Jacquelinet C, Reese P, Gourraud PA, Brouard S, Lefaucheur C, Loupy A; KTD-Innov Consortium. Design, cohort profile and comparison of the KTD-Innov study: a prospective multidimensional biomarker validation study in kidney allograft rejection. Eur J Epidemiol. 2024 May;39(5):549-564. doi: 10.1007/s10654-024-01112-w. Epub 2024 Apr 16.
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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.
Alexandre Loupy, Pr study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Transplant Rejection, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 3 inclusion and 3 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Concordance of invasive/non-invasive biomarkers with allograft rejection (time frame: month 12). 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 NCT03582436, 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 10 Feb 2022.