Predicting Mortality in Kidney Transplant Recipients
mBox
Development and Validation of a Prediction Model for Risk of Death in Kidney Transplant Recipients
1 other identifier
observational
13,000
4 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2004
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedAugust 1, 2024
July 1, 2024
20.4 years
July 25, 2024
July 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Patient death
Patient death
Up to 10 years after kidney transplantation
Study Arms (12)
Necker hospital from Paris, France
Kidney recipients from Necker hospital
Saint-Louis hospital from Paris, France
Kidney recipients from Saint-Louis hospital
Bichat hospital from Paris, France
Kidney recipients from Bichat hospital
Bretonneau hospital from Tours, France
Kidney recipients from Bretonneau hospital
Toulouse hospital, France
Kidney recipients from Toulouse hospital
KU Leuven, Belgium
Kidney recipients from KU Leuven
Liege hospital from Belgium
Kidney recipients from Liege hospital
Leiden University Medical Center from the Netherlands
Kidney recipients from Leiden University Medical Center
Hospital of the University of Pennsylvania from Philadelphia, US
Kidney recipients from Hospital of the University of Pennsylvania
Mayo Clinic from Phoenix, US
Kidney recipients from Mayo Clinic
UCSF database
Kidney recipients data from real-world UCSF database
AP-HP database
Kidney recipients data from real-world AP-HP database
Interventions
No intervention
Eligibility Criteria
Adult, de novo, kidney recipients who received only a kidney transplant
You may qualify if:
- Adult kidney recipients
You may not qualify if:
- Multi-organ transplantation
- Prior kidney transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Department of Medicine, Mayo Clinic
Phoenix, Arizona, 85054, United States
Bakar Computational Health Sciences Institute, University of California
San Francisco, California, 94158, United States
Penn Transplant Institute, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Loupy
Paris Institute for Transplantation and Organ Regeneration (PITOR)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2024
First Posted
August 1, 2024
Study Start
January 1, 2004
Primary Completion
June 1, 2024
Study Completion
August 1, 2024
Last Updated
August 1, 2024
Record last verified: 2024-07