Estimating Glomerular Filtration Rate in Kidney Transplant Recipients

Performances of Estimated Glomerular Filtration Rate Equations in Kidney Transplant Recipients

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation; Glomerular Filtration Rate
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 11412

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia
    • Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School of Medicine, University of Zagreb
• France
  • Lyon, France
    • Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon
  • Montpellier, France
    • Department of Nephrology, Centre Hospitalier Universitaire, Montpellier
  • Paris, 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
    • Kidney Transplant Department, Tenon Hospital, Assistance Publique - Hôpitaux de Paris
  • Saint-Étienne, France
    • Nephrology, Dialysis and Renal Transplantation Department, Hôpital Nord, CHU de Saint-Etienne, Jean Monnet University, Université de Lyon
  • Toulouse, France
    • Department of Nephrology and Organ Transplantation, CHU Rangueil
• Italy
  • Bergamo, Italy
    • Istituto di Ricerche Farmacologiche Mario Negri IRCCS
• United States
  • Minnesota
    • Rochester, Minnesota, United States
      • William J. von Liebig Centre for Transplantation and Clinical Regeneration, Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The development cohort consisted of kidney transplant recipients from 3 centres in France. The validation cohorts consisted kidney transplant recipients from 6 centers in Europe and 1 in the Unites states.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measured glomerular filtration rate (mGFR)	Isotopic measurements of GFR	Up to 15 years after kidney transplantation

Collaborators and Investigators

• Sponsor: Paris Translational Research Center for Organ Transplantation
• Investigators: Principal Investigator: Alexandre Loupy, MD, PhD, Paris Translational Research Center for Organ Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Glomerular filtration rate; Kidney transplantation; Equation; Prediction
• Other Study ID Numbers: KRSeGFR2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No