Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation

NCT04258891 | Completed

• 1 other identifier: DYNAKT
• Study Type: observational
• Target: 14,000
• Locations: 7 countries
• Sites: 18

Brief Summary

The incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Although some ESRD prediction models have been derived in the past years, none of these models are dynamic: they do not integrate the repeated measurements recorded throughout individuals' follow-up. As highlighted in several studies, kidney function repeated measurements (i.e., trajectories) are highly associated with graft survival after kidney transplantation. The investigators made the hypothesis that these trajectories may bring relevant information in the context of graft survival risk prediction model. Hence, combining these trajectories with standard graft survival risk factors may enhance prediction performance. This could permit to derive a robust tool that could be updated over time by continuously capturing patient' personal evolution.

Conditions

Kidney Transplant Failure

Keywords

Kidney Transplantation; Graft survival; Kidney function; Prediction; Dynamic

Outcome Measures

Primary Outcomes (1)

• Allograft survival probability

  Allograft survival probability, calculated from a dynamic prediction system, based on clinical, histological, immunological and estimated glomerular filtration rate and proteinuria repeated measurements, assessed at the time of risk evaluation and that can be updated thereafter.

  Up to 10 years after kidney transplantation

Secondary Outcomes (1)

• Added prognostic value

  Up to 10 years after kidney transplantation

Interventions

No intervention OTHER

Kidney recipients aged over 18 and of all sexes recruited from 2004 in European, North American and South American centers, who have estimated glomerular filtration rate and proteinuria follow-up and data from protocol and for cause biopsies for allograft survival assessment; Randomized controlled trials conducted over the past 20 years with available data on protocol biopsy within the first year and follow-up, clinical, biological and histological data.

Eligibility Criteria

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

Study Population

Kidney recipients aged over 18 and of all sexes recruited from 2004 in European and North American centers, who have estimated glomerular filtration rate and proteinuria repeated measurements, data from protocol and for cause biopsies, as well as immunological, clinical, functional parameters and survival data for allograft and patient survival assessment. Additional kidney recipients from RCTs with longitudinal data including baseline and follow-up clinical, functional, immunological and histological data.

You may qualify if:

• Kidney recipients transplanted after 2004
• Kidney recipients over 18 years of age
• Kidney recipients with at least two estimated glomerular filtration rate and proteinuria measurements after transplantation

You may not qualify if:

• Combined transplantation

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (18)

Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Division of Transplantation, Department of Surgery, Feinberg School of Medicine, Northwestern University

Chicago, Illinois, 60611, United States

Location

Department of Surgery, Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

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

Rochester, Minnesota, 55905, United States

Location

Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program

New York, New York, 10467, United States

Location

Unidad de Trasplante Renopáncreas, Centro de Educación Médica e Investigaciones Clínicas

Buenos Aires, 4102, Argentina

Location

Universidade Federal de São Paulo, Hospital do Rim, Escola Paulista de Medicina

São Paulo, 04038-002, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Renal Transplantation Service

São Paulo, 05403-000, Brazil

Location

Clinica Alemana de Santiago

Santiago, 3204, Chile

Location

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

Zagreb, 10000, Croatia

Location

Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy

Nancy, 54035, France

Location

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

Paris, 75010, France

Location

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

Paris, 75015, France

Location

Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch

Suresnes, 92150, France

Location

Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil

Toulouse, 31059, France

Location

Bretonneau Hospital, Nephrology and Immunology Department

Tours, 37000, France

Location

Department of Nephrology, Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (1)

• Raynaud M, Aubert O, Divard G, Reese PP, Kamar N, Yoo D, Chin CS, Bailly E, Buchler M, Ladriere M, Le Quintrec M, Delahousse M, Juric I, Basic-Jukic N, Crespo M, Silva HT Jr, Linhares K, Ribeiro de Castro MC, Soler Pujol G, Empana JP, Ulloa C, Akalin E, Bohmig G, Huang E, Stegall MD, Bentall AJ, Montgomery RA, Jordan SC, Oberbauer R, Segev DL, Friedewald JJ, Jouven X, Legendre C, Lefaucheur C, Loupy A. Dynamic prediction of renal survival among deeply phenotyped kidney transplant recipients using artificial intelligence: an observational, international, multicohort study. Lancet Digit Health. 2021 Dec;3(12):e795-e805. doi: 10.1016/S2589-7500(21)00209-0. Epub 2021 Oct 28.

  PMID: 34756569 DERIVED

Related Links

• Paris Transplant Group Website

Study Officials

• Alexandre Loupy, Professor

  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: February 4, 2020
• First Posted: February 6, 2020
• Study Start: January 1, 2004
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7); US (5); ES (1); CR (1); AR (1); CL (1); BR (2)