NCT02900040

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
288mo left

Started Jan 1994

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 1994Jan 2050

Study Start

First participant enrolled

January 1, 1994

Completed
22.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
33.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2050

Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

56 years

First QC Date

September 9, 2016

Last Update Submit

September 14, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • Proportion of participants with Overall Survival

    2 years

  • Proportion of participants with Overall Survival

    4 years

  • Proportion of participants with Overall Survival

    6 years

Secondary Outcomes (2)

  • expansion of effector memory CD8+ T cells dosage

    1 year

  • expansion of effector memory CD8+ T cells dosage

    6 years

Study Arms (1)

patients with kidney transplantations

patients with kidney transplantations

Other: kidney transplantation

Interventions

patients with kidney transplantations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eight French transplantation centers participate to the DIVAT network: Nantes, Paris Necker, Nancy and Montpellier since 1994, Toulouse since 1997, Lyon since 2006, and Paris Saint-Louis and Nice that joined the network since 2013. All patients over the age of 18 years, who received a renal transplant, are included. No other particular inclusion criteria exist.

You may qualify if:

  • over the age of 18 years
  • with renal transplant

You may not qualify if:

  • minor
  • pediatric transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Docteur Buron

Lyon, 69002, France

RECRUITING

Professeur Mourad

Montpellier, 34295, France

RECRUITING

Professeur Kessler

Nancy, 54035, France

RECRUITING

Professeur Ladriere

Nancy, 54035, France

RECRUITING

Pr Cassuto

Nice, 06003, France

RECRUITING

Professeur Kreis

Paris, 75184, France

RECRUITING

Professeur Legendre

Paris, 75184, France

RECRUITING

Professeur Rostaing

Toulouse, 31400, France

RECRUITING

Related Publications (2)

  • Choisy C, Foucher Y, Masset C, Maanaoui M, Lenain R, Rostaing L, Jouve T, Le Quintrec M, Serre JE, Morelon E, Charmetant X, Ladriere M, Girerd S, Sicard A, Gosset C, Mariat C, Claisse G, Giral M, Dantan E; DIVAT Consortium. Identification of Donor-recipient Interactions for a Relative Appraisal of Kidney Graft Marginality: A French Multicentric Cohort-based Study. Transplantation. 2025 Dec 1;109(12):e708-e717. doi: 10.1097/TP.0000000000005464. Epub 2025 Jul 14.

  • Danger R, Le Berre L, Cadoux M, Kerleau C, Papuchon E, Mai HL, Nguyen TV, Guerif P, Morelon E, Thaunat O, Legendre C, Anglicheau D, Lefaucheur C, Couzi L, Del Bello A, Kamar N, Le Quintrec M, Goutaudier V, Renaudin K, Giral M, Brouard S; DIVAT Consortium. Subclinical rejection-free diagnostic after kidney transplantation using blood gene expression. Kidney Int. 2023 Jun;103(6):1167-1179. doi: 10.1016/j.kint.2023.03.019. Epub 2023 Mar 27.

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood cells, serum, plasma, urine, m-RNA, and DNA of recipients and donors

MeSH Terms

Interventions

Kidney Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Magali Giral, PU-PH

    Nantes Universuty Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 14, 2016

Study Start

January 1, 1994

Primary Completion (Estimated)

January 1, 2050

Study Completion (Estimated)

January 1, 2050

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations