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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05229939
Other study ID # KRSeGFR2021
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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