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

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.

Conditions

• First Cadaveric Renal Graft

Interventions

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.

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Jean-Paul SOULILLOU, Professor · Nantes University Hospital

• Magali GIRAL, Doctor · Nantes University Hospital

• Maryvonne HOURMANT, Professor · Nantes University Hospital

• Diego CANTAROVICH, Doctor · Nantes University Hospital

• Jacques DANTAL, Professor · Nantes University Hospital

• Gilles BLANCHO, Professor · Nantes University Hospital

• Aurélie MEURETTE, Doctor · Nantes University Hospital

• Marie LINO, Doctor · Nantes University Hospital

• Georges MOURAD, Professor · University Hospital, Montpellier

• Lionel ROSTAING, Professor · University Hospital, Toulouse

• Dominique DURAND, Professor · University Hospital, Toulouse

• Christophe LEGENDRE, Professor · AP-HP (Hôpital Necker)

• Michèle KESSLER, Professor · CHU NANCY

• Emmanuel MORELON, Professor · Hospices Civils de Lyon

• Sameh DAOUD, Doctor · Hospices Civils de Lyon

• Cécile CHAUVET, Doctor · Hospices Civils de Lyon

• Olivier THAUNAT, Doctor · Hospices Civils de Lyon

• Jean-François SUBRA, Professor · University Hospital, Angers

• François BAYLE, Doctor · University Hospital, Grenoble

• Elisabeth CASSUTO, Doctor · CHU NICE

Study Design

Allocation

NA

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2011-05-31

Completion

2011-05-31

Countries

• France

Study Locations