Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation

Kidney Transplantation Clinical Trial

— DIVAT  

Official title:

The French DIVAT: a Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02900040
• Other study ID #: RC12_0452
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2016
• Last updated: September 14, 2016
• Start date: January 1994
• Est. completion date: January 2050

Study information

• Verified date: September 2016
• Source: Nantes University Hospital
• Contact: Magali Giral, PU-PH
• Phone: +33 (0)2 40 08 74 43
• Email: mgiral[@]chu-nantes.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The French DIVAT (standing for Données Informatisées et VAlidées en Transplantation in french, and in English "Computerized and VAlidated Data in Transplantation" ) cohort was Kicked off in 1994 by the Transplantation Urology Nephrology Institute of the Nantes University Hospital in France. The primary objective of this multicenter computerized database was to enable prospective clinical and epidemiological research studies concerning kidney transplant recipients, particularly focusing on mid- and long-term clinical outcomes, therapeutic strategies and public health issues. The patient-case system of the DIVAT cohort allows the monitoring of medical records of all patient-specific and allograft-specific data, including bio-banking since 2005. Data are collected from the date of transplantation until the graft failure, at each scheduled outpatient visit or hospital admission motivating by a new clinical, therapeutical or biological expression. The DIVAT cohort contains information on more than 11000 transplant recipients between 1994 and today, issued from 8 French university hospitals centers (the DIVAT Network is organized by a consortium agreement). 18% of all patients underwent retransplantation and 11% of all kidney transplants originated from living donors. The DIVAT network heavily works to ensure a high-quality data collection with the aim of exploring adequately the complex post-transplantation process. The Divat network encourage collaborations and enables interested researchers to submit a research project by completing a request form available on the DIVAT website (http://www.divat.fr/en) describing the context, objectives and design of the study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: January 2050
• Est. primary completion date: January 2050
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over the age of 18 years

• with renal transplant

Exclusion Criteria:

• minor

• pediatric transplantation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Other:
• kidney transplantation

Locations

Country	Name	City	State
France	Docteur Buron	Lyon
France	Professeur Mourad	Montpellier
France	Professeur Kessler	Nancy
France	Professeur Ladriere	Nancy
France	Pr Cassuto	Nice
France	Professeur Kreis	Paris
France	Professeur Legendre	Paris
France	Professeur Rostaing	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with Overall Survival		2 years	No
Primary	Proportion of participants with Overall Survival		4 years	No
Primary	Proportion of participants with Overall Survival		6 years	No
Secondary	expansion of effector memory CD8+ T cells dosage	potential marker for acute graft dysfunction	1 year	No
Secondary	expansion of effector memory CD8+ T cells dosage	potential marker for late graft dysfunction	6 years	No