Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft (Protocol DPRC Array)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft.

Conditions
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First Cadaveric Renal Graft

Intervention / Treatment
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* Biological: DNA chip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Patients aged 18 to 65 years old receiving a first cadaveric renal graft. | Biological: DNA chip<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal graft, chronic rejection, tolerance, DNA chip, biopsy