First Cadaveric Renal GraftNCT00746057
Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft (Protocol DPRC Array)
A study testing DNA chip in people with First Cadaveric Renal Graft, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of the study is to explore the possibility to identify, at an early stage after a renal graft and from blood samples collected within first months after graft, a predictive transcriptional profile of long term occurence of graft operational tolerance or chronic rejection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- First Cadaveric Renal Graft
- What is being tested?
- DNA chip
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to May 2011
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years old,
- Donor's age ≤ 60 years old,
- Patients receiving a first cadaveric renal graft,
- Patients taking immunosuppressant treatment including an induction with Simulect at day 0 and day 4, FK 506 (Prograf®) associated with Cellcept and steroids (for three months),
- Patients don't taking indispensable anticoagulant treatment.
Who cannot join
- Patient's age < 18 or > 65 years old,
- Donor's age ≥ 60 years old,
- Pregnant women or breast feeding women,
- Patients receiving a retransplantation, a kidney and pancreas graft or a graft from a living donor,
- Patients taking immunosuppressant treatment without FK 506 (Prograf®), Cellcept and steroids.
- Patients with coagulation troubles or taking indispensable anticoagulant treatment,
- No biopsy before graft.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft.
The aim of the study is to explore the possibility to identify, at an early stage after a renal graft and from blood samples collected within first months after graft, a predictive transcriptional profile of long term occurence of graft operational tolerance or chronic rejection.
The aim of the study is to determine an early transcriptional profile of chronic rejection in the transcriptome of mononuclear blood cells. Validation and predictivity of transcriptional analysis will be based on graft function and graft histology one year after transplantation.The other aim is to determine an early transcriptional profile of operational tolerance in the same patients using a DNA chip dedicated including two lists of genes discriminating tolerant patients who are stopped immunosuppressant treatment for over a year.
To allow statistical analysis of 100 patients followed one year after graft, patients not assessable at one year due to early termination of study will be replaced.
- Conditions
- First Cadaveric Renal Graft
- Being tested
- DNA chip
- Keywords
- Renal graft, chronic rejection, tolerance, DNA chip, biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA chipBiological
One biopsy is realized before graft, another biopsy is realized one year after graft and a blood sample is collected 3 months after graft to realize DNA chip. Blood samples are also collected at day 0, day 1, month 3, month 6 and month 12 to analyze biochemistry, proteinuria, haematology, creatinine clearance and immunology at day 0, month 3 and month 12.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients aged 18 to 65 years old receiving a first cadaveric renal graft. Receives: Biological: DNA chip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation.
Measured: 3 months
Secondary outcomes (1)
Correlation of the transcriptional profile at 3 months after transplantation with histological features of the kidney graft at one year of follow-up.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startMay 2006
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: The number of included patients is sufficient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Cadaveric Renal GraftStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Paul SOULILLOU, Professor, Principal investigator, Nantes University HospitalMagali GIRAL, Doctor, Study chair, Nantes University HospitalMaryvonne HOURMANT, Professor, Study chair, Nantes University HospitalDiego CANTAROVICH, Doctor, Study chair, Nantes University HospitalJacques DANTAL, Professor, Study chair, Nantes University HospitalGilles BLANCHO, Professor, Study chair, Nantes University HospitalAurélie MEURETTE, Doctor, Study chair, Nantes University HospitalMarie LINO, Doctor, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746057
- Sponsor's protocol ID
- 06/2-E
- Status last verified
- Sep 2013
- First submitted
- 2 Sep 2008
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft.
- ClinicalTrials.gov ID
- NCT00746057
- Acronym / sponsor ID
- 06/2-E
- Conditions
- First Cadaveric Renal Graft
- Keywords
- Renal graft, chronic rejection, tolerance, DNA chip, biopsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of included patients is sufficient.
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Sep 2008 (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 the study is to explore the possibility to identify, at an early stage after a renal graft and from blood samples collected within first months after graft, a predictive transcriptional profile of long term occurence of graft operational tolerance or chronic rejection.
The aim of the study is to determine an early transcriptional profile of chronic rejection in the transcriptome of mononuclear blood cells. Validation and predictivity of transcriptional analysis will be based on graft function and graft histology one year after transplantation.The other aim is to determine an early transcriptional profile of operational tolerance in the same patients using a DNA chip dedicated including two lists of genes discriminating tolerant patients who are stopped immunosuppressant treatment for over a year.
To allow statistical analysis of 100 patients followed one year after graft, patients not assessable at one year due to early termination of study will be replaced.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Biological: DNA chipPatients aged 18 to 65 years old receiving a first cadaveric renal graft. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 65 years old,
- Donor's age ≤ 60 years old,
- Patients receiving a first cadaveric renal graft,
- Patients taking immunosuppressant treatment including an induction with Simulect at day 0 and day 4, FK 506 (Prograf®) associated with Cellcept and steroids (for three months),
- Patients don't taking indispensable anticoagulant treatment.
Key exclusion criteria (7 listed)
- Patient's age < 18 or > 65 years old,
- Donor's age ≥ 60 years old,
- Pregnant women or breast feeding women,
- Patients receiving a retransplantation, a kidney and pancreas graft or a graft from a living donor,
- Patients taking immunosuppressant treatment without FK 506 (Prograf®), Cellcept and steroids.
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 |
|---|---|---|
| DNA chipOne biopsy is realized before graft, another biopsy is realized one year after graft and a blood sample is collected 3 months after graft to realize DNA chip. Blood samples are also collected at day 0, day 1, month 3, month 6 and month 12 to analyze biochemistry, proteinuria, haematology, creatinine clearance and immunology at day 0, month 3 and month 12. | Biological | 1 |
Primary outcome
Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation.
Time frame: 3 months
1 secondary outcome
Correlation of the transcriptional profile at 3 months after transplantation with histological features of the kidney graft at one year of follow-up.
Time frame: One year
Results and safety
The study was stopped early (reason given: The number of included patients is sufficient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
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.
Jean-Paul SOULILLOU, Professor principal investigator
Nantes University Hospital
Magali GIRAL, Doctor study chair
Nantes University Hospital
Maryvonne HOURMANT, Professor study chair
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DNA chip in people with First Cadaveric Renal Graft, 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 5 inclusion and 7 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 30 Sep 2013. 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: The number of included patients is sufficient.). 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.
What does the primary outcome measure?
Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation. (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 30 Sep 2013.