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OpenTrials
Completed

NCT Number: NCT05229939

Estimating Glomerular Filtration Rate 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data

Primary outcomes

  1. Measured glomerular filtration rate (mGFR)

    Time frame: Up to 15 years after kidney transplantation

    Isotopic measurements of GFR

Sponsors and collaborators

Lead sponsor

Paris Translational Research Center for Organ Transplantation

Other

Registry information

Official study title

Performances of Estimated Glomerular Filtration Rate Equations in Kidney Transplant Recipients

Important dates

Study start
2000
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2022
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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