Kidney TransplantationNCT01280708
Protocol DIVAT-Uro
An observational study of Kidney Transplantation and Pancreas-kidney Transplantation, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation - Urology) is to organize a thematic network in urology traced on NetWork DIVAT to supplement the medical and biological data of DIVAT existing cohort with parameters of surgical transplantation of kidney and pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Pancreas-kidney Transplantation
- What is being tested?
- Capture data
- How many people
- 1,616 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2012to 31 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant.
Who may be able to join
- Patients aged over 18 years
- Patients received a kidney transplant or a simultaneous pancreas-kidney transplant
- Patients who read the newsletter and signed the consent form on the computerization of data
Who cannot join
- Patients aged under 18 years
- Patients who did not sign the consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment of a National Thematic Network in Urology for the Extension of the Cohort DIVAT (Données Informatisées et Validées en Transplantation) in Surgical Parameters of Renal and Pancreatic Transplant Patients : An Innovative Tool for the Promotion of Epidemiological Studies, Identification of Risk Factors and Good Practices in the Domain of Transplant Surgery
The aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation - Urology) is to organize a thematic network in urology traced on NetWork DIVAT to supplement the medical and biological data of DIVAT existing cohort with parameters of surgical transplantation of kidney and pancreas. These data will concern the transplantation itself and the events and complications related to surgery occurring throughout the follow-up. The collection will involve patients in the cohort DIVAT and future patients. This project will allow us to have the sufficiency of surgical transplantation by increasing the quantity and quality of information gathered thus avoiding the biases commonly upbraided against the retrospective studies. Finally, by supplementing it with new parameters, it will strengthen the medical and scientific interest of the cohort DIVAT and will open new perspectives for clinical trials in surgery and work in epidemiology.Networking of urologists and the expansion of the base DIVAT would carry out research in epidemiology and factors that may play a role in the outcome of renal and pancreatic transplantation. It would also help to define good practices. The first study from the proposed network DIVAT-Uro is assessing the impact of vesico-ureteric reflux on the occurrence of urinary tract infections and effects on survival of the transplant in the recipient adult.
- Being tested
- Capture data
- Keywords
- Urology, Nephrology, Renal and pancreas transplantation, Data base, Epidemiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capture dataOther
Capture and standardization of data of patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant from data sources will be performed by clinical research associates.The quality of data will be validated by cross annual audits. The statistical analysis will be made on a case by case according to clinical objectives.
| Study group | Role | What they receive |
|---|---|---|
| Capture data | Not described Receives: Other: Capture data |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study start2 Jan 2012
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Why it stopped: This database did not have the desired inclusions or results and is therefore not sufficiently usable. This base is therefore abandoned in favor of a base on the pancreas much more promising both nationally and internationally.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,616 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges KARAM, Profesor, Principal investigator, Nantes University HospitalLionel BADET, Profesor, Study chair, Hospices Civils de LyonFrançois IBORRA, Doctor, Study chair, CHU de MontpellierJacques HUBERT, Profesor, Study chair, Central Hospital, Nancy, FranceArnaud MEJEAN, Profesor, Study chair, Hôpital Necker - AP-HPPascal RISCHMANN, Profesor, Study chair, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280708
- Sponsor's protocol ID
- BRD/09/11-E
- Status last verified
- Sep 2011
- First submitted
- 19 Jan 2011
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a National Thematic Network in Urology for the Extension of the Cohort DIVAT (Données Informatisées et Validées en Transplantation) in Surgical Parameters of Renal and Pancreatic Transplant Patients : An Innovative Tool for the Promotion of Epidemiological Studies, Identification of Risk Factors and Good Practices in the Domain of Transplant Surgery
- ClinicalTrials.gov ID
- NCT01280708
- Acronym / sponsor ID
- BRD/09/11-E
- Keywords
- Urology, Nephrology, Renal and pancreas transplantation, Data base, Epidemiology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This database did not have the desired inclusions or results and is therefore not sufficiently usable. This base is therefore abandoned in favor of a base on the pancreas much more promising both nationally and internationally.
- Enrolment
- 1,616 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2012 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 21 Jan 2011 (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 aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation - Urology) is to organize a thematic network in urology traced on NetWork DIVAT to supplement the medical and biological data of DIVAT existing cohort with parameters of surgical transplantation of kidney and pancreas. These data will concern the transplantation itself and the events and complications related to surgery occurring throughout the follow-up. The collection will involve patients in the cohort DIVAT and future patients. This project will allow us to have the sufficiency of surgical transplantation by increasing the quantity and quality of information gathered thus avoiding the biases commonly upbraided against the retrospective studies. Finally, by supplementing it with new parameters, it will strengthen the medical and scientific interest of the cohort DIVAT and will open new perspectives for clinical trials in surgery and work in epidemiology.Networking of urologists and the expansion of the base DIVAT would carry out research in epidemiology and factors that may play a role in the outcome of renal and pancreatic transplantation. It would also help to define good practices. The first study from the proposed network DIVAT-Uro is assessing the impact of vesico-ureteric reflux on the occurrence of urinary tract infections and effects on survival of the transplant in the recipient adult.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capture data | – | Other: Capture data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant.
Key inclusion criteria (3 listed)
- Patients aged over 18 years
- Patients received a kidney transplant or a simultaneous pancreas-kidney transplant
- Patients who read the newsletter and signed the consent form on the computerization of data
Key exclusion criteria (2 listed)
- Patients aged under 18 years
- Patients who did not sign the consent form
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 |
|---|---|---|
| Capture dataCapture and standardization of data of patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant from data sources will be performed by clinical research associates.The quality of data will be validated by cross annual audits. The statistical analysis will be made on a case by case according to clinical objectives. | Other | Capture data |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: This database did not have the desired inclusions or results and is therefore not sufficiently usable. This base is therefore abandoned in favor of a base on the pancreas much more promising both nationally and internationally.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
Related trials for Kidney Transplantation
RecruitingPhase 1
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Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
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Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
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RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
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. This study is not recruiting at the moment.
Georges KARAM, Profesor principal investigator
Nantes University Hospital
Lionel BADET, Profesor study chair
Hospices Civils de Lyon
François IBORRA, Doctor study chair
CHU de Montpellier
1 site 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 and Pancreas-kidney Transplantation, run by Nantes University Hospital at 1 site 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 3 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: stopped early, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: This database did not have the desired inclusions or results and is therefore not sufficiently usable. This base is therefore abandoned in favor of a base on the pancreas much more promising both nationally and internationally.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 17 Sep 2021.