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

Not Applicable

Terminated

• Conditions: First Cadaveric Renal Graft
• Interventions: Biological: DNA chip

• Registration Number: NCT00746057
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	DNA chip	Patients aged 18 to 65 years old receiving a first cadaveric renal graft.

Primary Outcome Measures

Name	Time	Method
Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation.	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France