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Trial record 4 of 2109 for:    Kidney Transplantation

Rejection Diagnosis in Kidney Transplants Patients (KTD-innov)

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ClinicalTrials.gov Identifier: NCT03582436
Recruitment Status : Not yet recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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 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.


Condition or disease Intervention/treatment
Kidney Transplantation Transplant Rejection Graft Survival Procedure: Kidney transplantation

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 7 French centres : 3 Parisian ones: Necker hospital, Saint-Louis Hospital and Bichat hospital and 4 regional ones: CHU Nantes, Toulouse and Bordeaux, 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.

Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective KTD-innov Cohort of Kidney Transplants Patients
Estimated Study Start Date : July 10, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prospective cohort
Kidney transplantation
Procedure: Kidney transplantation

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

Other Names:
  • Transcriptomics analysis
  • Non-HLA antibodies analysis
  • Omics blood analysis
  • Urine chemokines analysis,
  • Characteristics of anti HLA DSA analysis




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Association of non-invasive biomarkers with different subtypes of rejection [ Time Frame: month 12 ]
    Association of non-invasive biomarkers with different subtypes of rejection

  2. Association of gene sets with different subtypes of rejection in the biopsy. [ Time Frame: month 12 ]
    Association of gene sets with different subtypes of rejection in the biopsy.

  3. Reclassification capacity of gene sets and non-invasive biomarkers to define allograft rejection. [ Time Frame: month 12 ]
    Reclassification capacity of gene sets and non-invasive biomarkers to define allograft rejection

  4. Variation of the non-invasive biomarker signature of allograft rejection [ Time Frame: month 12 ]
    ariation of the non-invasive biomarker signature of allograft rejection as a response to the standard of care in kidney transplant recipients.

  5. Variation of the gene set signature [ Time Frame: month 12 ]
    Variation of the gene set signature of allograft rejection from the biopsy as a response to the standard of care in kidney transplant recipients.

  6. Cumulative incidence of antibody-mediated rejection (ABMR) [ Time Frame: month 12 ]
    Cumulative incidence of antibody-mediated rejection (ABMR) that occurs between D0 and M12 (ABMR that meets Banff 2015 criteria)

  7. Cumulative incidence of T-cell-mediated rejection (TCMR) [ Time Frame: month 12 ]
    Cumulative incidence of T-cell-mediated rejection (TCMR) that occurs between D0 and M12 (TCMR that meets Banff 2015 criteria)

  8. Treatment failure rate [ Time Frame: month 12 ]
    Treatment failure rate defined as the occurrence of 1) biopsy proven ABMR and/or TCMR, 2) graft loss, 3) patient death

  9. Graft and patient survival [ Time Frame: month 12 ]
    Graft and patient survival at M6 and M12 post-transplantation

  10. Histological evidence of ABMR and/or TCMR on protocol biopsies [ Time Frame: month 12 ]
    Histological evidence of ABMR and/or TCMR on protocol biopsies without other clinical findings at M3 and M12 post-transplantation

  11. Overall pathological changes, including chronic ABMR [ Time Frame: month 12 ]
    Overall pathological changes, including chronic ABMR, on protocol biopsies M3 and M12 post-transplantation

  12. Incidence of delayed graft function [ Time Frame: month 12 ]
    Incidence of delayed graft function (DGF) post-transplantation

  13. Cumulative incidence and duration of dialysis. [ Time Frame: month 12 ]
    Cumulative incidence and duration of dialysis between 7 days and M12 post- transplantation


Biospecimen Retention:   Samples Without DNA
blood samples, urines samples, kidney biopsy samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
New kidney transplants patients
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582436


Contacts
Contact: Carmen Lefaucheur, Pr +33 1 42 49 49 49 carmenlefaucheur4@gmail.com
Contact: Philippe Gallula, Mr +33 1 57 27 83 17 philippe.gallula@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Alexandre Loupy, Pr Institut National de la Santé Et de la Recherche Médicale, France

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03582436     History of Changes
Other Study ID Numbers: K170909J
2018-A00090-55 ( Registry Identifier: IDRCB number )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Kidney
Allogeneic transplantation
Cohort study
Rejection
Biomarkers
Integrative medicine