Estimating Glomerular Filtration Rate in Kidney Transplant Recipients

NCT ID: NCT05229939

Last Updated: 2022-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11412 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-01

Study Completion Date

2021-01-01

Brief Summary

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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

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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.

Conditions

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Kidney Transplantation Glomerular Filtration Rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Development cohort

kidney transplant recipients in 3 centres in France: Necker, Saint-Louis and Toulouse hospitals

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Paris Translational Research Center for Organ Transplantation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Loupy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Paris Translational Research Center for Organ Transplantation

Locations

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William J. von Liebig Centre for Transplantation and Clinical Regeneration, Mayo Clinic

Rochester, Minnesota, United States

Site Status

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

Zagreb, , Croatia

Site Status

Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon

Lyon, , France

Site Status

Department of Nephrology, Centre Hospitalier Universitaire, Montpellier

Montpellier, , France

Site Status

Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris

Paris, , France

Site Status

Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris

Paris, , France

Site Status

Kidney Transplant Department, Tenon Hospital, Assistance Publique - Hôpitaux de Paris

Paris, , France

Site Status

Nephrology, Dialysis and Renal Transplantation Department, Hôpital Nord, CHU de Saint-Etienne, Jean Monnet University, Université de Lyon

Saint-Etienne, , France

Site Status

Department of Nephrology and Organ Transplantation, CHU Rangueil

Toulouse, , France

Site Status

Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Bergamo, , Italy

Site Status

Countries

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United States Croatia France Italy

References

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Raynaud M, Al-Awadhi S, Juric I, Divard G, Lombardi Y, Basic-Jukic N, Aubert O, Dubourg L, Masson I, Mariat C, Prie D, Pernin V, Le Quintrec M, Larson TS, Stegall MD, Bikbov B, Ruggenenti P, Mesnard L, Ibrahim HN, Nielsen MB, Matas AJ, Nankivell BJ, Benjamens S, Pol RA, Bakker SJL, Jouven X, Legendre C, Kamar N, Smith BH, Wadei HM, Durrbach A, Vincenti F, Remuzzi G, Lefaucheur C, Bentall AJ, Loupy A. Race-free estimated glomerular filtration rate equation in kidney transplant recipients: development and validation study. BMJ. 2023 May 31;381:e073654. doi: 10.1136/bmj-2022-073654.

Reference Type DERIVED
PMID: 37257905 (View on PubMed)

Other Identifiers

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KRSeGFR2021

Identifier Type: -

Identifier Source: org_study_id

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