Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft (Protocol DPRC Array)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nantes, France
- CHU de Nantes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 1
Patients aged 18 to 65 years old receiving a first cadaveric renal graft.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation.
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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One year
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Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 06/2-E
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