Estimating Glomerular Filtration Rate in Kidney Transplant Recipients

Completed

• Conditions: Glomerular Filtration Rate; Kidney Transplantation
• Interventions: Other: No intervention

• Registration Number: NCT05229939
• Lead Sponsor: Paris Translational Research Center for Organ Transplantation

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.

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:

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.

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11412

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation cohort 5	No intervention	kidney transplant recipients from Mayo Clinic Hospital, USA
Validation cohort 3	No intervention	kidney transplant recipients from Tenon Hospital, France
Validation cohort 7	No intervention	kidney transplant recipients from Zagreb hospital, Croatia
Validation cohort 1	No intervention	kidney transplant recipients from Montpellier Hospital, France
Validation cohort 2	No intervention	kidney transplant recipients from Lyon Hospital, France
Validation cohort 4	No intervention	kidney transplant recipients from Saint-Etienne Hospital, France
Development cohort	No intervention	kidney transplant recipients in 3 centres in France: Necker, Saint-Louis and Toulouse hospitals
Validation cohort 6	No intervention	kidney transplant recipients from Bergamo hospital, Italy

Primary Outcome Measures

Name	Time	Method
Measured glomerular filtration rate (mGFR)	Up to 15 years after kidney transplantation	Isotopic measurements of GFR

Trial Locations

Locations (10)

William J. von Liebig Centre for Transplantation and Clinical Regeneration, Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School of Medicine, University of Zagreb; 🇭🇷 Zagreb, Croatia

Department of Nephrology, Centre Hospitalier Universitaire, Montpellier; 🇫🇷 Montpellier, France

Nephrology, Dialysis and Renal Transplantation Department, Hôpital Nord, CHU de Saint-Etienne, Jean Monnet University, Université de Lyon; 🇫🇷 Saint-Étienne, France

Istituto di Ricerche Farmacologiche Mario Negri IRCCS; 🇮🇹 Bergamo, Italy

Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, France

Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon; 🇫🇷 Lyon, France

Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, France

Kidney Transplant Department, Tenon Hospital, Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, France

Department of Nephrology and Organ Transplantation, CHU Rangueil; 🇫🇷 Toulouse, France