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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: First Cadaveric Renal Graft

Treatments: Biological: DNA chip

Study type: Interventional

Funder types: Other

Identifiers

NCT00746057

06/2-E

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

134 participants in 1 patient group

1

Other group

Description:

Patients aged 18 to 65 years old receiving a first cadaveric renal graft.

Treatment:

Biological: DNA chip