Trajectories of Glomerular Filtration Rate and Progression to End Stage Renal Disease After Kidney Transplantation

Status unconfirmed

Conditions studied: Kidney Transplant Failure, Kidney Function Issue

In brief

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.

Key facts

Study ID

NCT04226859

Run by

Paris Translational Research Center for Organ Transplantation

People needed

14000

Starts

2000-01-01

Expected to finish

2020-06-01

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Kidney recipients transplanted after 2000
• Kidney recipients over 18 years of age
• Kidney recipients with at least two eGFR measurements after transplantation

You may not qualify if…

• Combined transplantation

Where it is running

• Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris — Paris, France (enrolling)
• Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris — Paris, France (enrolling)
• 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
• Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch — Suresnes, France
• Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil — Toulouse, France
• Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center — Los Angeles, California, United States
• Bretonneau Hospital, Nephrology and Immunology Department — Tours, France
• Department of Surgery, Johns Hopkins University School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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