Estimating Glomerular Filtration Rate in Kidney Transplant Recipients

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05229939
Study type	Observational
Source	Paris Translational Research Center for Organ Transplantation
Contact
Status	Completed
Phase
Start date	January 1, 2000
Completion date	January 1, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.