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Estimating Glomerular Filtration Rate in Kidney Transplant Recipients

Performances of Estimated Glomerular Filtration Rate Equations in Kidney Transplant Recipients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05229939
Enrollment
11412
Registered
2022-02-08
Start date
2000-01-01
Completion date
2021-01-01
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerular Filtration Rate, Kidney Transplantation

Keywords

Glomerular filtration rate, Kidney transplantation, Equation, Prediction

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.

Interventions

OTHERNo intervention

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

Sponsors

Paris Translational Research Center for Organ Transplantation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measured glomerular filtration rate (mGFR)Up to 15 years after kidney transplantationIsotopic measurements of GFR

Countries

Croatia, France, Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026