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Predicting Mortality in Kidney Transplant Recipients (mBox)

P

Paris Translational Research Center for Organ Transplantation

Status

Invitation-only

Conditions

Death

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06531967
mBox_001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

13,000 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult kidney recipients

Exclusion criteria

  • Multi-organ transplantation
  • Prior kidney transplant

Trial design

13,000 participants in 12 patient groups

Necker hospital from Paris, France
Description:
Kidney recipients from Necker hospital
Treatment:
Other: No intervention
Saint-Louis hospital from Paris, France
Description:
Kidney recipients from Saint-Louis hospital
Treatment:
Other: No intervention
Bichat hospital from Paris, France
Description:
Kidney recipients from Bichat hospital
Treatment:
Other: No intervention
Bretonneau hospital from Tours, France
Description:
Kidney recipients from Bretonneau hospital
Treatment:
Other: No intervention
Toulouse hospital, France
Description:
Kidney recipients from Toulouse hospital
Treatment:
Other: No intervention
KU Leuven, Belgium
Description:
Kidney recipients from KU Leuven
Treatment:
Other: No intervention
Liege hospital from Belgium
Description:
Kidney recipients from Liege hospital
Treatment:
Other: No intervention
Leiden University Medical Center from the Netherlands
Description:
Kidney recipients from Leiden University Medical Center
Treatment:
Other: No intervention
Hospital of the University of Pennsylvania from Philadelphia, US
Description:
Kidney recipients from Hospital of the University of Pennsylvania
Treatment:
Other: No intervention
Mayo Clinic from Phoenix, US
Description:
Kidney recipients from Mayo Clinic
Treatment:
Other: No intervention
UCSF database
Description:
Kidney recipients data from real-world UCSF database
Treatment:
Other: No intervention
AP-HP database
Description:
Kidney recipients data from real-world AP-HP database
Treatment:
Other: No intervention

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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