Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
13000 participants
OBSERVATIONAL
2004-01-01
2024-08-01
Brief Summary
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However, according to a literature review the investigators performed, studies attempting to develop a kidney recipient death prediction model suffer from many shortcomings, including the lack of key risk factors, use of biased registry data, small sample size, lack of external validation in different countries and subpopulations, and short follow-up.
The present study thus aimed to address these limitations and develop a robust, generalizable kidney recipient death prediction model.
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Detailed Description
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Although the number of kidney transplantations performed each year has increased as well, it follows a lower pace than the increase of individuals on the waiting-list, resulting in an organ shortage. There is therefore a need to optimize allograft allocation by identifying the high-risk patients who may not benefit from a transplant and improve the clinical decision-making after transplant to ensure that each patient survives as long as possible.
In this context, a kidney recipient death prediction model may improve transplant clinical practice, allowing for the ability to evaluate the individual risk of post transplant mortality, already before undergoing transplantation, thereby guiding decision making. However, developing such a model is a very difficult task, as death after kidney transplantation depends on many parameters, such as donor age, history or cause of death, imaging parameters, patients' past medical history (e.g. diabetes, dialysis duration, hypertension), patients' biological parameters, as well as the function of the allograft, which depends on patients' immunological factors, or allograft related parameters such as HLA mismatches or cold ischemia time.
The goal of the present study was therefore to identify the determinants of death after kidney transplantation, and to develop and validate a prediction model that would help optimize allograft allocation and post-transplant patient management, using a large, international, highly phenotyped cohort of kidney recipients with extensive data collection and long-term follow-up.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Necker hospital from Paris, France
Kidney recipients from Necker hospital
No intervention
No intervention
Saint-Louis hospital from Paris, France
Kidney recipients from Saint-Louis hospital
No intervention
No intervention
Bichat hospital from Paris, France
Kidney recipients from Bichat hospital
No intervention
No intervention
Bretonneau hospital from Tours, France
Kidney recipients from Bretonneau hospital
No intervention
No intervention
Toulouse hospital, France
Kidney recipients from Toulouse hospital
No intervention
No intervention
KU Leuven, Belgium
Kidney recipients from KU Leuven
No intervention
No intervention
Liege hospital from Belgium
Kidney recipients from Liege hospital
No intervention
No intervention
Leiden University Medical Center from the Netherlands
Kidney recipients from Leiden University Medical Center
No intervention
No intervention
Hospital of the University of Pennsylvania from Philadelphia, US
Kidney recipients from Hospital of the University of Pennsylvania
No intervention
No intervention
Mayo Clinic from Phoenix, US
Kidney recipients from Mayo Clinic
No intervention
No intervention
UCSF database
Kidney recipients data from real-world UCSF database
No intervention
No intervention
AP-HP database
Kidney recipients data from real-world AP-HP database
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior kidney transplant
18 Years
100 Years
ALL
No
Sponsors
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Paris Translational Research Center for Organ Transplantation
OTHER
Responsible Party
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Principal Investigators
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Alexandre Loupy
Role: PRINCIPAL_INVESTIGATOR
Paris Institute for Transplantation and Organ Regeneration (PITOR)
Locations
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Department of Medicine, Mayo Clinic
Phoenix, Arizona, United States
Bakar Computational Health Sciences Institute, University of California
San Francisco, California, United States
Penn Transplant Institute, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Department of Nephrology and Renal Transplantation, University Hospitals Leuven
Leuven, , Belgium
Division of Nephrology, University Hospital Liège (CHU)
Liège, , Belgium
Necker hospital
Paris, , France
Saint-Louis hospital
Paris, , France
Tenon hospital
Paris, , France
Department of Nephrology and Organ Transplantation, Toulouse University Hospital
Toulouse, , France
Department of Nephrology and Clinical Immunology, University Hospital of Tours
Tours, , France
Leiden Transplant Center, Leiden University Medical Center
Leiden, , Netherlands
Countries
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Other Identifiers
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mBox_001
Identifier Type: -
Identifier Source: org_study_id
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