Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation

Kidney Transplant Failure Clinical Trial

— DYNAKT  

Official title:

Development and Validation of a Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04258891
• Other study ID #: DYNAKT
• Status: Completed
• Start date: January 1, 2004
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Paris Translational Research Center for Organ Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14000
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Failure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Argentina	Unidad de Trasplante Renopáncreas, Centro de Educación Médica e Investigaciones Clínicas	Buenos Aires
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Renal Transplantation Service	São Paulo
Brazil	Universidade Federal de São Paulo, Hospital do Rim, Escola Paulista de Medicina	São Paulo
Chile	Clinica Alemana de Santiago	Santiago
Croatia	Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb	Zagreb
France	Department of Nephrology, Centre Hospitalier Universitaire de Montpellier	Montpellier
France	Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy	Nancy
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	Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch	Suresnes
France	Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil	Toulouse
France	Bretonneau Hospital, Nephrology and Immunology Department	Tours
Spain	Department of Nephrology, Hospital del Mar	Barcelona
United States	Department of Surgery, Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Division of Transplantation, Department of Surgery, Feinberg School of Medicine, Northwestern University	Chicago	Illinois
United States	Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center	Los Angeles	California
United States	Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program	New York	New York
United States	William J. von Liebig Center 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,  Argentina,  Brazil,  Chile,  Croatia,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Added prognostic value	Added prognostic value of the dynamic prediction system over standard of care monitoring of kidney transplant recipients based on single value of estimated glomerular filtration rate and proteinuria	Up to 10 years after kidney transplantation

External Links

•   Paris Transplant Group Website