Estimating Glomerular Filtration Rate in Kidney Transplant Recipients

NCT05229939 | Completed

• 1 other identifier: KRSeGFR2021
• Study Type: observational
• Target: 11,412
• Locations: 4 countries
• Sites: 10

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.

Conditions

Kidney Transplantation; Glomerular Filtration Rate

Keywords

Glomerular filtration rate; Kidney transplantation; Equation; Prediction

Outcome Measures

Primary Outcomes (1)

• Measured glomerular filtration rate (mGFR)

  Isotopic measurements of GFR

  Up to 15 years after kidney transplantation

Study Arms (8)

Development cohort

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

Other: No intervention

Validation cohort 1

kidney transplant recipients from Montpellier Hospital, France

Other: No intervention

Validation cohort 2

kidney transplant recipients from Lyon Hospital, France

Other: No intervention

Validation cohort 3

kidney transplant recipients from Tenon Hospital, France

Other: No intervention

Validation cohort 4

kidney transplant recipients from Saint-Etienne Hospital, France

Other: No intervention

Validation cohort 5

kidney transplant recipients from Mayo Clinic Hospital, USA

Other: No intervention

Validation cohort 6

kidney transplant recipients from Bergamo hospital, Italy

Other: No intervention

Validation cohort 7

kidney transplant recipients from Zagreb hospital, Croatia

Other: No intervention

Interventions

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

Development cohort; Validation cohort 1; Validation cohort 2; Validation cohort 3; Validation cohort 4; Validation cohort 5; Validation cohort 6; Validation cohort 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The development cohort consisted of kidney transplant recipients from 3 centres in France. The validation cohorts consisted kidney transplant recipients from 6 centers in Europe and 1 in the Unites states.

You may qualify if:

• 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.

You may not qualify if:

• Combined transplantation

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (10)

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

Rochester, Minnesota, United States

Location

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

Zagreb, Croatia

Location

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

Lyon, France

Location

Department of Nephrology, Centre Hospitalier Universitaire, Montpellier

Montpellier, France

Location

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

Paris, France

Location

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

Paris, France

Location

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

Paris, France

Location

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

Saint-Etienne, France

Location

Department of Nephrology and Organ Transplantation, CHU Rangueil

Toulouse, France

Location

Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Bergamo, Italy

Location

Related Publications (1)

• 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.

  PMID: 37257905 DERIVED

Study Officials

• Alexandre Loupy, MD, PhD

  Paris Translational Research Center for Organ Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: January 1, 2000
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1); IT (1); FR (7); US (1)