Estimating Glomerular Filtration Rate in Kidney Transplant Recipients

Paris Translational Research Center for Organ Transplantation

Status: Completed

Conditions: Glomerular Filtration Rate; Kidney Transplantation

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05229939

KRSeGFR2021

Details and patient eligibility

About

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.

Full 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:

1. Develop new kidney-recipient-specific (KRS) GFR equations and compare their performances with the standard GFR equations
2. Investigate whether the use of race increasers the performances of the new kidney-recipient-specific (KRS) GFR equations
3. 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.

Enrollment: 11,412 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Living or deceased donor kidney recipient transplanted between 01/01/2000 and 01/01/2021.
• Men or women over 18 years of age.
• Written informed consent at the time of transplantation for the center database.

Exclusion criteria

• Combined transplantation

Trial design

11,412 participants in 8 patient groups

Development cohort

Description:

kidney transplant recipients in 3 centres in France: Necker, Saint-Louis and Toulouse hospitals

Treatment:

Other: No intervention

Validation cohort 1

Description:

kidney transplant recipients from Montpellier Hospital, France

Treatment:

Other: No intervention

Validation cohort 2

Description:

kidney transplant recipients from Lyon Hospital, France

Treatment:

Other: No intervention

Validation cohort 3

Description:

kidney transplant recipients from Tenon Hospital, France

Treatment:

Other: No intervention

Validation cohort 4

Description:

kidney transplant recipients from Saint-Etienne Hospital, France

Treatment:

Other: No intervention

Validation cohort 5

Description:

kidney transplant recipients from Mayo Clinic Hospital, USA

Treatment:

Other: No intervention

Validation cohort 6

Description:

kidney transplant recipients from Bergamo hospital, Italy

Treatment:

Other: No intervention

Validation cohort 7

Description:

kidney transplant recipients from Zagreb hospital, Croatia

Treatment:

Other: No intervention