Clinical trial NCT00746057: Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft (Protocol DPRC Array)
Official title: Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: First Cadaveric Renal Graft
Keywords: Renal graft
chronic rejection
tolerance
DNA chip
biopsy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation.
timeFrame: 3 months
Secondary outcomes:
measure: Correlation of the transcriptional profile at 3 months after transplantation with histological features of the kidney graft at one year of follow-up.
timeFrame: One year
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Jean-Paul SOULILLOU, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Magali GIRAL, Doctor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Maryvonne HOURMANT, Professor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Diego CANTAROVICH, Doctor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Jacques DANTAL, Professor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Gilles BLANCHO, Professor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Aurélie MEURETTE, Doctor
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Marie LINO, Doctor
role: STUDY_CHAIR
affiliation: University Hospital, Montpellier
name: Georges MOURAD, Professor
role: STUDY_CHAIR
affiliation: CHU Toulouse
name: Lionel ROSTAING, Professor
role: STUDY_CHAIR
affiliation: CHU Toulouse
name: Dominique DURAND, Professor
role: STUDY_CHAIR
affiliation: AP-HP (Hôpital Necker)
name: Christophe LEGENDRE, Professor
role: STUDY_CHAIR
affiliation: CHU NANCY
name: Michèle KESSLER, Professor
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Emmanuel MORELON, Professor
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Sameh DAOUD, Doctor
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Cécile CHAUVET, Doctor
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Olivier THAUNAT, Doctor
role: STUDY_CHAIR
affiliation: University Hospital, Angers
name: Jean-François SUBRA, Professor
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: François BAYLE, Doctor
role: STUDY_CHAIR
affiliation: CHU NICE
name: Elisabeth CASSUTO, Doctor
role: STUDY_CHAIR
References: