Estimating Glomerular Filtration Rate in Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:

Performances of Estimated Glomerular Filtration Rate Equations in Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229939
• Other study ID #: KRSeGFR2021
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: January 1, 2021

Study information

• Verified date: August 2022
• Source: Paris Translational Research Center for Organ Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11412
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerular Filtration Rate
• Kidney Transplantation

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Paris Translational Research Center for Organ Transplantation

Countries where clinical trial is conducted

United States,  Croatia,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured glomerular filtration rate (mGFR)	Isotopic measurements of GFR	Up to 15 years after kidney transplantation