Kidney Transplant Failure Clinical Trial
— TRAJAKTOfficial title:
Multicenter International Observational Study to Identify eGFR Trajectories and Their Determinants, and to Build a Multidimensional Prediction System to Predict the Probabilities of Belonging to eGFR Trajectories
NCT number | NCT04226859 |
Other study ID # | TRAJAKT |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 2000 |
Est. completion date | June 2020 |
The gold standard for characterizing chronic kidney disease (CKD) is the glomerular
filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys
for patient monitoring and therapeutic management and ultimately guides decision-making about
whether a patient needs renal replacement therapy. In particular, the National Kidney
Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several
studies, the eGFR slope or change has been found to be strongly associated with end stage
renal disease (ESRD).
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.
Status | Recruiting |
Enrollment | 14000 |
Est. completion date | June 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Kidney recipients transplanted after 2000 - Kidney recipients over 18 years of age - Kidney recipients with at least two eGFR measurements after transplantation Exclusion Criteria: - Combined transplantation |
Country | Name | City | State |
---|---|---|---|
Belgium | Department of Nephrology and Renal Transplantation, University Hospitals Leuven | Leuven | |
Croatia | Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb | Zagreb | |
France | 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, Necker Hospital, Assistance Publique - Hôpitaux de Paris | Paris | |
France | Kidney Transplant Department, Saint-Louis 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 | |
United States | Department of Surgery, Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center | Los Angeles | California |
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 | William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Paris Translational Research Center for Organ Transplantation |
United States, Belgium, Croatia, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | eGFR trajectories | eGFR trajectories probabilities, calculated from a prediction system (based on clinical, histological, immunological, and functional factors) assessed at 1-year post transplantation. | Up to 10 years after kidney transplantation |
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