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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-05-31

Brief Summary

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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

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Conditions

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First Cadaveric Renal Graft

Keywords

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Renal graft chronic rejection tolerance DNA chip biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

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

Group Type OTHER

DNA chip

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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CHU de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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06/2-E

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

DNA chip

Interventions

DNA chip

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Nantes University Hospital

Principal Investigators

Jean-Paul SOULILLOU, Professor

Magali GIRAL, Doctor

Maryvonne HOURMANT, Professor

Diego CANTAROVICH, Doctor

Jacques DANTAL, Professor

Gilles BLANCHO, Professor

Aurélie MEURETTE, Doctor

Marie LINO, Doctor

Georges MOURAD, Professor

Lionel ROSTAING, Professor

Dominique DURAND, Professor

Christophe LEGENDRE, Professor

Michèle KESSLER, Professor

Emmanuel MORELON, Professor

Sameh DAOUD, Doctor

Cécile CHAUVET, Doctor

Olivier THAUNAT, Doctor

Jean-François SUBRA, Professor

François BAYLE, Doctor

Elisabeth CASSUTO, Doctor

Locations

CHU de Nantes

Countries

Other Identifiers

06/2-E