Estimating Glomerular Filtration Rate in Kidney Transplant Recipients
Study Details
Study Description
Brief Summary
Accurate estimation of the glomerular filtration rate (GFR) is crucial for the management of kidney recipients, since it is the most predictive parameter of allograft failure that drives patient monitoring and decision-making. Standard and recent race-free GFR equations have been developed in native kidneys, but their performances in transplant kidney population remains unknown. We aimed at developing a kidney-transplant-specific GFR equation, and comparing its performance to standard GFR equations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Historically, GFR equations, which predict the measured GFR (mGFR), were developed on patients with native kidneys and were further validated and used in kidney recipients. However, studies have shown significant heterogeneity in the performances of GFR equations when applied in kidney recipients, which may be attributed to variations and intrinsic characteristics specific to the transplant population. We thus made the hypothesis that GFR equations developed on a large, well-phenotyped kidney recipient cohort might achieve good performances in predicting mGFR.
The project therefore aims to:
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Develop new kidney-recipient-specific (KRS) GFR equations and compare their performances with the standard GFR equations
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Investigate whether the use of race increasers the performances of the new kidney-recipient-specific (KRS) GFR equations
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Evaluate the effects of the new equations on the chronic kidney disease (CKD) prevalence and GFR stage
This study will provide us with data of kidney transplant patients that may allow the development of a new KRS GFR equation.
A new KRS GFR equation that presents with increased performances, as compared to current GFR equations, will improve the GFR calculation in kidney recipients, and therefore improve clinical decisions and the long-term kidney allograft management. Decisions regarding the return to dialysis or placement on the transplant waiting list will be taken with more accuracy and therefore potentially improve the financial allocation of kidney transplantation for the society.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Development cohort kidney transplant recipients in 3 centres in France: Necker, Saint-Louis and Toulouse hospitals |
Other: No intervention
Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data
|
| Validation cohort 1 kidney transplant recipients from Montpellier Hospital, France |
Other: No intervention
Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data
|
| Validation cohort 2 kidney transplant recipients from Lyon Hospital, France |
Other: No intervention
Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data
|
| Validation cohort 3 kidney transplant recipients from Tenon Hospital, France |
Other: No intervention
Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data
|
| Validation cohort 4 kidney transplant recipients from Saint-Etienne Hospital, France |
Other: No intervention
Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data
|
| Validation cohort 5 kidney transplant recipients from Mayo Clinic Hospital, USA |
Other: No intervention
Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data
|
| Validation cohort 6 kidney transplant recipients from Bergamo hospital, Italy |
Other: No intervention
Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data
|
| Validation cohort 7 kidney transplant recipients from Zagreb hospital, Croatia |
Other: No intervention
Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data
|
Outcome Measures
Primary Outcome Measures
- Measured glomerular filtration rate (mGFR) [Up to 15 years after kidney transplantation]
Isotopic measurements of GFR
Eligibility Criteria
Criteria
Inclusion Criteria:
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Living or deceased donor kidney recipient transplanted between 01/01/2000 and 01/01/2021.
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Men or women over 18 years of age.
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Written informed consent at the time of transplantation for the center database.
Exclusion Criteria:
• Combined transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | William J. von Liebig Centre for Transplantation and Clinical Regeneration, Mayo Clinic | Rochester | Minnesota | United States | |
| 2 | Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School of Medicine, University of Zagreb | Zagreb | Croatia | ||
| 3 | Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon | Lyon | France | ||
| 4 | Department of Nephrology, Centre Hospitalier Universitaire, Montpellier | Montpellier | France | ||
| 5 | Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris | Paris | France | ||
| 6 | Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris | Paris | France | ||
| 7 | Kidney Transplant Department, Tenon Hospital, Assistance Publique - Hôpitaux de Paris | Paris | France | ||
| 8 | Nephrology, Dialysis and Renal Transplantation Department, Hôpital Nord, CHU de Saint-Etienne, Jean Monnet University, Université de Lyon | Saint-Étienne | France | ||
| 9 | Department of Nephrology and Organ Transplantation, CHU Rangueil | Toulouse | France | ||
| 10 | Istituto di Ricerche Farmacologiche Mario Negri IRCCS | Bergamo | Italy |
Sponsors and Collaborators
- Paris Translational Research Center for Organ Transplantation
Investigators
- Principal Investigator: Alexandre Loupy, MD, PhD, Paris Translational Research Center for Organ Transplantation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KRSeGFR2021