Predicting Mortality in Kidney Transplant Recipients

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.

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Key information

Conditions

Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult kidney recipients

Exclusion criteria

Multi-organ transplantation
Prior kidney transplant

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

Patient death

Time frame: Up to 10 years after kidney transplantation

Patient death

Sponsors and collaborators

Lead sponsor

Paris Translational Research Center for Organ Transplantation

Other

Registry information

Official study title

Development and Validation of a Prediction Model for Risk of Death in Kidney Transplant Recipients

Acronym: mBox

Important dates

Study start: 2004
Primary completion: 2024
Study completion: 2024
First posted: Aug 1, 2024
Registry last updated: Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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