Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft (Protocol DPRC Array)
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|ClinicalTrials.gov Identifier: NCT00746057|
Recruitment Status : Terminated (The number of included patients is sufficient.)
First Posted : September 3, 2008
Last Update Posted : September 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|First Cadaveric Renal Graft||Biological: DNA chip||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Patients aged 18 to 65 years old receiving a first cadaveric renal graft.
Biological: DNA chip
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.
- Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation. [ Time Frame: 3 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746057
|CHU de Nantes|
|Principal Investigator:||Jean-Paul SOULILLOU, Professor||CHU Nantes|
|Study Chair:||Magali GIRAL, Doctor||CHU Nantes|
|Study Chair:||Maryvonne HOURMANT, Professor||CHU Nantes|
|Study Chair:||Diego CANTAROVICH, Doctor||CHU Nantes|
|Study Chair:||Jacques DANTAL, Professor||CHU Nantes|
|Study Chair:||Gilles BLANCHO, Professor||CHU Nantes|
|Study Chair:||Aurélie MEURETTE, Doctor||CHU Nantes|
|Study Chair:||Marie LINO, Doctor||CHU Nantes|
|Study Chair:||Georges MOURAD, Professor||University Hospital, Montpellier|
|Study Chair:||Lionel ROSTAING, Professor||CHU Toulouse|
|Study Chair:||Dominique DURAND, Professor||CHU Toulouse|
|Study Chair:||Christophe LEGENDRE, Professor||AP-HP (Hôpital Necker)|
|Study Chair:||Michèle KESSLER, Professor||CHU Nancy|
|Study Chair:||Emmanuel MORELON, Professor||CHU LYON|
|Study Chair:||Sameh DAOUD, Doctor||CHU LYON|
|Study Chair:||Cécile CHAUVET, Doctor||CHU LYON|
|Study Chair:||Olivier THAUNAT, Doctor||CHU LYON|
|Study Chair:||Jean-François SUBRA, Professor||University Hospital, Angers|
|Study Chair:||François BAYLE, Doctor||University Hospital, Grenoble|
|Study Chair:||Elisabeth CASSUTO, Doctor||CHU Nice|