Trajectories of Glomerular Filtration Rate and Progression to End Stage Renal Disease After Kidney Transplantation
NCT ID: NCT04226859
Last Updated: 2020-01-18
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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UNKNOWN
14000 participants
OBSERVATIONAL
2000-01-31
2020-06-30
Brief Summary
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However, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described.
An unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease.
Therefore, this study aims:
1. To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models;
2. To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions;
3. To investigate the associations of the eGFR trajectories with the progression to ESRD and death.
Based on the results, the investigators will provide an easily accessible tool to calculate personalized probabilities of belonging to eGFR trajectories after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.
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Detailed Description
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Chronic kidney disease (CKD) now affects 850 million individuals worldwide, exceeding the global prevalence of diabetes, cancer and HIV/AIDS. In addition, end-stage renal disease affects 7.4 million individuals and mortality rate for individuals burdened by kidney disease is now estimated at 5 to 10 million individuals each year. Therefore, developing better diagnostic and treatment approaches for the kidney disease epidemic is a global priority, as leading professional societies and health agencies have emphasized (the US Food \& Drug Administration, the National Kidney Foundation, the European Medicines Agency, the European Society of Organ Transplantation, the American Society for Transplantation and the American Society of Transplant Surgeons).
However, current approaches for investigating the relationship between eGFR course and outcomes such as ESRD and mortality have been limited by registries with an overall lack on granular data, including infrequent eGFR measurements for a single patient and convenience clinical samples. An unsupervised longitudinal approach to determine patient eGFR evolution may bring an original perspective to the traditional clinical interpretation of kidney function based on limited eGFR measurements, short-term follow-up, and standard statistical approach.
Main Outcome(s) and Measure(s)
* eGFR trajectories
* Determinants of eGFR trajectories
* Associations of eGFR trajectories with ESRD and death
* Prediction system that will provide the personalized probabilities of belonging to eGFR trajectories
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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No intervention
Kidney recipients aged over 18 and of all sexes recruited from 2000 in European and North American centers, who have eGFR follow-up and data from protocol and for cause biopsies available for allograft survival assessment; Randomized controlled trials conducted over the past 20 years with available data on protocol biopsy within the first year and follow up clinical, biological and histological data.
Eligibility Criteria
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Inclusion Criteria
* Kidney recipients over 18 years of age
* Kidney recipients with at least two eGFR measurements after transplantation
Exclusion Criteria
18 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, Professor
Role: PRINCIPAL_INVESTIGATOR
Paris Translational Research Center for Organ Transplantation
Locations
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Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center
Los Angeles, California, United States
Department of Surgery, Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic
Rochester, Minnesota, United States
Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program
New York, New York, United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States
Department of Nephrology and Renal Transplantation, University Hospitals Leuven
Leuven, , Belgium
Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb
Zagreb, , Croatia
Department of Nephrology, Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy
Nancy, , France
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris
Paris, , France
Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris
Paris, , France
Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch
Suresnes, , France
Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil
Toulouse, , France
Bretonneau Hospital, Nephrology and Immunology Department
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Carmen Lefaucheur, MD
Role: primary
Related Links
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Paris Transplant Group Website
Other Identifiers
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TRAJAKT
Identifier Type: -
Identifier Source: org_study_id
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