Function of Renal TransplantTUFEVNCT01443013
Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient
An observational study of Function of Renal Transplant, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Function of Renal Transplant
- What is being tested?
- Renal Transplant
- How many people
- 266 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Jan 2015
- 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: All Renal transplant recipients
Who may be able to join
- All renal transplant recipients aged >18 years with informed consent
- Kidney transplantation in one of the centers participating in the study all patients registered on the waiting list to the Agency of Biomedicine
- Supported by a conventional procedure
- Informed consent signed.
- No pregnancy or lactation in progress.
- Serology HIV and (HCV negative suppressed by amendment n°2)
- No contraindication for a biopsy at 1 year post transplant
Who cannot join
- Positive crossmatch, focal segmental glomerulosclerosis (FSGS) as primary nephropathy, HIV positive population
- Absence of registration on the waiting list for transplantation with the Agency of Biomedicine
- HIV-positive serology
- Chronic renal failure secondary to focal segmental hyalinosis
- Cross-match historical or cross match of the day positive T or B awareness
- Patient included in a Memorandum of industry (suppressed by amendment n°1)
- No affiliation to a social security scheme
- Patients with early failure due to immediate complications (4%) will be included but will not be considered for analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value Analysis of Messenger Ribonucleic Acid (mRNA) Urinary Expression of Foxp3 and Vimentin on Graft Outcome in Renal Transplant Recipient: National Prospective Study
This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.
Read the detailed description
This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function,
- Conditions
- Function of Renal Transplant
- Being tested
- Renal Transplant
- Keywords
- Tolerance, Renal Transplantation, Chronic allograft nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal TransplantOther
urinary sample at month 3, 6 and 12
| Study group | Role | What they receive |
|---|---|---|
| Cohort of Renal Transplant recipients | Not described Receives: Other: Renal Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foxp3 and Vimentin mRNA expression
evaluation at month 9 suppressed by amendment n°2
Measured: at Month 1,3,6 and 12
Secondary outcomes (1)
Renal biopsy
Measured: at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Function of Renal TransplantStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Grimbert, MD PHD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443013
- Sponsor's protocol ID
- NI08031
- Other IDs
- AOM09031
- Acronym
- TUFEV
- Status last verified
- Oct 2015
- First submitted
- 9 Aug 2011
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aquino-Dias EC, Joelsons G, da Silva DM, Berdichevski RH, Ribeiro AR, Veronese FJ, Goncalves LF, Manfro RC. Non-invasive diagnosis of acute rejection in kidney transplants with delayed graft function. Kidney Int. 2008 Apr;73(7):877-84. doi: 10.1038/sj.ki.5002795. Epub 2008 Jan 23.
PubMed 18216781
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value Analysis of Messenger Ribonucleic Acid (mRNA) Urinary Expression of Foxp3 and Vimentin on Graft Outcome in Renal Transplant Recipient: National Prospective Study
- ClinicalTrials.gov ID
- NCT01443013
- Acronym / sponsor ID
- TUFEV / NI08031
- Conditions
- Function of Renal Transplant
- Keywords
- Tolerance, Renal Transplantation, Chronic allograft nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Sep 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.
This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.
Detailed description
This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of Renal Transplant recipients | – | Other: Renal Transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Renal transplant recipients
Key inclusion criteria (7 listed)
- All renal transplant recipients aged >18 years with informed consent
- Kidney transplantation in one of the centers participating in the study all patients registered on the waiting list to the Agency of Biomedicine
- Supported by a conventional procedure
- Informed consent signed.
- No pregnancy or lactation in progress.
Key exclusion criteria (8 listed)
- Positive crossmatch, focal segmental glomerulosclerosis (FSGS) as primary nephropathy, HIV positive population
- Absence of registration on the waiting list for transplantation with the Agency of Biomedicine
- HIV-positive serology
- Chronic renal failure secondary to focal segmental hyalinosis
- Cross-match historical or cross match of the day positive T or B awareness
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 |
|---|---|---|
| Renal Transplanturinary sample at month 3, 6 and 12 | Other | Cohort of Renal Transplant recipients |
Primary outcome
Foxp3 and Vimentin mRNA expression
Time frame: at Month 1,3,6 and 12
evaluation at month 9 suppressed by amendment n°2
1 secondary outcome
Renal biopsy
Time frame: at Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Background: PubMed 18216781Aquino-Dias EC, Joelsons G, da Silva DM, Berdichevski RH, Ribeiro AR, Veronese FJ, Goncalves LF, Manfro RC. Non-invasive diagnosis of acute rejection in kidney transplants with delayed graft function. Kidney Int. 2008 Apr;73(7):877-84. doi: 10.1038/sj.ki.5002795. Epub 2008 Jan 23.
Related trials for Function of Renal Transplant
RecruitingPhase 2/3
CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
Kidney Pancreas Transplantation
Active, not recruitingPhase 2
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Delayed Graft Function
Not yet recruiting
Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
Kidney Failure, Chronic, Kidney Transplantation
Recruiting
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
Delayed Graft Function, Kidney Transplantation
Not yet recruiting
TxAccess and Dd-cfDNA for Improved Care of Patients With Delayed Graft Function
Delayed Graft Function
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.
Philippe Grimbert, MD PHD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Function of Renal Transplant, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 20 Oct 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Foxp3 and Vimentin mRNA expression (time frame: at Month 1,3,6 and 12). 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 NCT01443013, which also lists 1 linked publication.
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 20 Oct 2015.