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The number of included patients is sufficient.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Patients aged 18 to 65 years old receiving a first cadaveric renal graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA chip | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the transcriptional profile at 3 months after transplantation with histological features of the kidney graft at one year of follow-up. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul SOULILLOU, Professor | Nantes University Hospital | Principal Investigator |
| Magali GIRAL, Doctor | Nantes University Hospital | Study Chair |
| Maryvonne HOURMANT, Professor | Nantes University Hospital | Study Chair |
| Diego CANTAROVICH, Doctor | Nantes University Hospital | Study Chair |
| Jacques DANTAL, Professor | Nantes University Hospital | Study Chair |
| Gilles BLANCHO, Professor | Nantes University Hospital | Study Chair |
| Aurélie MEURETTE, Doctor | Nantes University Hospital | Study Chair |
| Marie LINO, Doctor | Nantes University Hospital | Study Chair |
| Georges MOURAD, Professor | University Hospital, Montpellier | Study Chair |
| Lionel ROSTAING, Professor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | France |
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| ID | Term |
|---|---|
| D020411 | Oligonucleotide Array Sequence Analysis |
| ID | Term |
|---|---|
| D009693 | Nucleic Acid Hybridization |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D017421 | Sequence Analysis |
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|
| University Hospital, Toulouse |
| Study Chair |
| Dominique DURAND, Professor | University Hospital, Toulouse | Study Chair |
| Christophe LEGENDRE, Professor | AP-HP (Hôpital Necker) | Study Chair |
| Michèle KESSLER, Professor | Central Hospital, Nancy, France | Study Chair |
| Emmanuel MORELON, Professor | Hospices Civils de Lyon | Study Chair |
| Sameh DAOUD, Doctor | Hospices Civils de Lyon | Study Chair |
| Cécile CHAUVET, Doctor | Hospices Civils de Lyon | Study Chair |
| Olivier THAUNAT, Doctor | Hospices Civils de Lyon | Study Chair |
| Jean-François SUBRA, Professor | University Hospital, Angers | Study Chair |
| François BAYLE, Doctor | University Hospital, Grenoble | Study Chair |
| Elisabeth CASSUTO, Doctor | Centre Hospitalier Universitaire de Nice | Study Chair |
| D046228 | Microarray Analysis |
| D046208 | Microchip Analytical Procedures |
| D015336 | Molecular Probe Techniques |