Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 9:30 AM
Study NCT ID:
NCT00746057
Status:
TERMINATED
Last Update Posted:
2013-09-30
First Post:
2008-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft (Protocol DPRC Array)
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft.
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The number of included patients is sufficient.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: