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

First Cadaveric Renal Graft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00746057
• Other study ID #: 06/2-E
• Status: Terminated
• Phase: N/A
• First received: September 2, 2008
• Last updated: September 27, 2013
• Start date: May 2006
• Est. completion date: May 2011

Study information

• Verified date: September 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 134
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• First Cadaveric Renal Graft

Intervention

Biological:
• DNA chip
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.

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation.		3 months	No
Secondary	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	No