Predicting Mortality in Kidney Transplant Recipients

NCT ID: NCT06531967

Last Updated: 2024-08-01

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

13000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-01

Study Completion Date

2024-08-01

Brief Summary

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Accurately predicting kidney recipient risk of death has a crucial interest because of the organ shortage, the need to optimize allograft allocation by identifying 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.

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.

Detailed Description

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The number of individuals suffering from end-stage chronic renal disease (ESRD) worldwide has increased over time, exceeding seven million of patients in 2020. For individuals with ESRD, kidney transplantation is the best treatment in terms of patient survival, quality of life and from a cost-effective standpoint, as compared with dialysis, even in comorbid or elderly populations.

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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Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Necker hospital from Paris, France

Kidney recipients from Necker hospital

No intervention

Intervention Type OTHER

No intervention

Saint-Louis hospital from Paris, France

Kidney recipients from Saint-Louis hospital

No intervention

Intervention Type OTHER

No intervention

Bichat hospital from Paris, France

Kidney recipients from Bichat hospital

No intervention

Intervention Type OTHER

No intervention

Bretonneau hospital from Tours, France

Kidney recipients from Bretonneau hospital

No intervention

Intervention Type OTHER

No intervention

Toulouse hospital, France

Kidney recipients from Toulouse hospital

No intervention

Intervention Type OTHER

No intervention

KU Leuven, Belgium

Kidney recipients from KU Leuven

No intervention

Intervention Type OTHER

No intervention

Liege hospital from Belgium

Kidney recipients from Liege hospital

No intervention

Intervention Type OTHER

No intervention

Leiden University Medical Center from the Netherlands

Kidney recipients from Leiden University Medical Center

No intervention

Intervention Type OTHER

No intervention

Hospital of the University of Pennsylvania from Philadelphia, US

Kidney recipients from Hospital of the University of Pennsylvania

No intervention

Intervention Type OTHER

No intervention

Mayo Clinic from Phoenix, US

Kidney recipients from Mayo Clinic

No intervention

Intervention Type OTHER

No intervention

UCSF database

Kidney recipients data from real-world UCSF database

No intervention

Intervention Type OTHER

No intervention

AP-HP database

Kidney recipients data from real-world AP-HP database

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult kidney recipients

Exclusion Criteria

* Multi-organ transplantation
* Prior kidney transplant
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paris Translational Research Center for Organ Transplantation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Bakar Computational Health Sciences Institute, University of California

San Francisco, California, United States

Site Status

Penn Transplant Institute, Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Department of Nephrology and Renal Transplantation, University Hospitals Leuven

Leuven, , Belgium

Site Status

Division of Nephrology, University Hospital Liège (CHU)

Liège, , Belgium

Site Status

Necker hospital

Paris, , France

Site Status

Saint-Louis hospital

Paris, , France

Site Status

Tenon hospital

Paris, , France

Site Status

Department of Nephrology and Organ Transplantation, Toulouse University Hospital

Toulouse, , France

Site Status

Department of Nephrology and Clinical Immunology, University Hospital of Tours

Tours, , France

Site Status

Leiden Transplant Center, Leiden University Medical Center

Leiden, , Netherlands

Site Status

Countries

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United States Belgium France Netherlands

Other Identifiers

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mBox_001

Identifier Type: -

Identifier Source: org_study_id

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