Kidney TransplantationDIVATNCT02900040
Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation
An observational study of Kidney Transplantation, run by Nantes University Hospital at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- kidney transplantation
- How many people
- 30,000 participants
- Where
- 8 sitesFrance
- Study dates
- Jan 1994to Jan 2050
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- over the age of 18 years
- with renal transplant
Who cannot join
- minor
- pediatric transplantation
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Docteur Buron
Lyon, 69002
- Recruiting
Professeur Mourad
Montpellier, 34295
- Recruiting
Professeur Kessler
Nancy, 54035
- Recruiting
Professeur Ladriere
Nancy, 54035
- Recruiting
Pr Cassuto
Nice, 06003
- Recruiting
Professeur Kreis
Paris, 75184
- Recruiting
Professeur Legendre
Paris, 75184
- Recruiting
Professeur Rostaing
Toulouse, 31400
About this study
Official title: The French DIVAT: a Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation
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
- Conditions
- Kidney Transplantation
- Being tested
- kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney transplantationOther
| Study group | Role | What they receive |
|---|---|---|
| patients with kidney transplantations | patients with kidney transplantations Receives: Other: kidney transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with Overall Survival
Measured: 2 years
Proportion of participants with Overall Survival
Measured: 4 years
Proportion of participants with Overall Survival
Measured: 6 years
Secondary outcomes (2)
expansion of effector memory CD8+ T cells dosage
potential marker for acute graft dysfunction
Measured: 1 year
expansion of effector memory CD8+ T cells dosage
potential marker for late graft dysfunction
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 1994
- Primary completionJan 2050 (estimated)
- Study completionJan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magali Giral, PU-PH, Principal investigator, Nantes Universuty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900040
- Sponsor's protocol ID
- RC12_0452
- Acronym
- DIVAT
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berthelot L, Degauque N, Cappelier L, Sailliet N, Mathe C, Brinas F, Dupuy A, Boussamet L, Tilly G, Colas L, Chesneau M, Kerleau C, Giral M, Danger R, Mai HL, Yeremenko N, Brouard S; Divat Consortium. IgA-Producing B Cells Exert Regulatory Function through Granzyme B in Kidney Allograft Tolerance. Kidney360. 2026 Jun 1;7(6):1251-1261. doi: 10.34067/KID.0000001054. Epub 2026 Jan 27.
PubMed 41591822Maanaoui M, Lenain R, Petit V, Dujardin A, Morelon E, Charmetant X, Le Quintrec M, Serre JE, Ladriere M, Girerd S, Masset C, Sicard A, Gosset C, Hamroun A, Kerleau C, Garandeau C, Provot F, Giral M, Hazzan M; DIVAT Consortium. Donor Characteristics Associated With Graft Loss and Delayed Graft Function in Very-Aged Kidney Donors: An Observational Multicentric Study. Transpl Int. 2025 Nov 18;38:14862. doi: 10.3389/ti.2025.14862. eCollection 2025.
PubMed 41340865Choisy 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.
PubMed 40653616Danger 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.
PubMed 36990211
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The French DIVAT: a Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02900040
- Acronym / sponsor ID
- DIVAT / RC12_0452
- Conditions
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 1994
- Primary completion
- Jan 2050 (estimated)
- Study completion
- Jan 2050 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with kidney transplantations | – | Other: kidney transplantationpatients with kidney transplantations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- over the age of 18 years
- with renal transplant
Key exclusion criteria (2 listed)
- minor
- pediatric transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kidney transplantation | Other | patients with kidney transplantations |
Primary outcome
Proportion of participants with Overall Survival
Time frame: 2 years
Proportion of participants with Overall Survival
Time frame: 4 years
Proportion of participants with Overall Survival
Time frame: 6 years
2 secondary outcomes
expansion of effector memory CD8+ T cells dosage
Time frame: 1 year
expansion of effector memory CD8+ T cells dosage
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Derived from this study: PubMed 41591822Berthelot L, Degauque N, Cappelier L, Sailliet N, Mathe C, Brinas F, Dupuy A, Boussamet L, Tilly G, Colas L, Chesneau M, Kerleau C, Giral M, Danger R, Mai HL, Yeremenko N, Brouard S; Divat Consortium. IgA-Producing B Cells Exert Regulatory Function through Granzyme B in Kidney Allograft Tolerance. Kidney360. 2026 Jun 1;7(6):1251-1261. doi: 10.34067/KID.0000001054. Epub 2026 Jan 27.
- Derived from this study: PubMed 41340865Maanaoui M, Lenain R, Petit V, Dujardin A, Morelon E, Charmetant X, Le Quintrec M, Serre JE, Ladriere M, Girerd S, Masset C, Sicard A, Gosset C, Hamroun A, Kerleau C, Garandeau C, Provot F, Giral M, Hazzan M; DIVAT Consortium. Donor Characteristics Associated With Graft Loss and Delayed Graft Function in Very-Aged Kidney Donors: An Observational Multicentric Study. Transpl Int. 2025 Nov 18;38:14862. doi: 10.3389/ti.2025.14862. eCollection 2025.
- Derived from this study: PubMed 40653616Choisy 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.
- Derived from this study: PubMed 36990211Danger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magali Giral, PU-PH principal investigator
Nantes Universuty Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Nantes University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali Giral, PU-PH (+33 (0)2 40 08 74 43, mgiral@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with Overall Survival (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02900040, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.