Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation

NCT ID: NCT04258891

Last Updated: 2020-09-16

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

14000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-01

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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850 million individuals suffer from chronic kidney disease (CKD), while diabetes, cancer, and HIV/AIDS affect 422, 42, and 37 million individuals, respectively. End stage renal disease (ESRD) hence places a heavy burden on health systems worldwide. Linked to that, the kidney-disease-associated mortality rate worldwide has risen over the past decade, now causing the death of 5 to 10 million individuals every year.

In kidney transplantation, numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, sometimes leading to graft failure. Current approaches for investigating the relationship between these factors and graft failure have been limited by standard statistical approaches and by registries with an overall lack on granular data, including infrequent kidney function measurements for a single patient and convenience clinical samples. Identifying the determinants of graft failure with a dynamic approach may bring an original perspective to the traditional graft survival risk prediction model that are impeded by their reliance on low-granularity datasets, cross-sectional parameters, and limited follow-up.

Conditions

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Kidney Transplant Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Combined transplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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, Professor

Role: PRINCIPAL_INVESTIGATOR

Paris Translational Research Center for Organ Transplantation

Locations

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

Los Angeles, California, United States

Site Status

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

Chicago, Illinois, United States

Site Status

Department of Surgery, Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

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

Rochester, Minnesota, United States

Site Status

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

New York, New York, United States

Site Status

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

Buenos Aires, , Argentina

Site Status

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

São Paulo, , Brazil

Site Status

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

São Paulo, , Brazil

Site Status

Clinica Alemana de Santiago

Santiago, , Chile

Site Status

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

Zagreb, , Croatia

Site Status

Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

Site Status

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

Nancy, , France

Site Status

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

Paris, , France

Site Status

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

Paris, , France

Site Status

Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch

Suresnes, , France

Site Status

Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil

Toulouse, , France

Site Status

Bretonneau Hospital, Nephrology and Immunology Department

Tours, , France

Site Status

Department of Nephrology, Hospital del Mar

Barcelona, , Spain

Site Status

Countries

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United States Argentina Brazil Chile Croatia France Spain

References

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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.

Reference Type DERIVED
PMID: 34756569 (View on PubMed)

Related Links

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https://www.paristransplantgroup.org

Paris Transplant Group Website

Other Identifiers

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DYNAKT

Identifier Type: -

Identifier Source: org_study_id

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