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

This study has been terminated.
(The number of included patients is sufficient.)
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00746057
First received: September 2, 2008
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
First Cadaveric Renal Graft
 Biological: DNA chip

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of the transcriptional profile at 3 months after transplantation with histological features of the kidney graft at one year of follow-up. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: May 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Patients aged 18 to 65 years old receiving a first cadaveric renal graft.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746057

Locations
France
CHU de Nantes
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Jean-Paul SOULILLOU, Professor CHU Nantes
Study Chair: Magali GIRAL, Doctor CHU Nantes
Study Chair: Maryvonne HOURMANT, Professor CHU Nantes
Study Chair: Diego CANTAROVICH, Doctor CHU Nantes
Study Chair: Jacques DANTAL, Professor CHU Nantes
Study Chair: Gilles BLANCHO, Professor CHU Nantes
Study Chair: Aurélie MEURETTE, Doctor CHU Nantes
Study Chair: Marie LINO, Doctor CHU Nantes
Study Chair: Georges MOURAD, Professor University Hospital, Montpellier
Study Chair: Lionel ROSTAING, Professor CHU Toulouse
Study Chair: Dominique DURAND, Professor CHU Toulouse
Study Chair: Christophe LEGENDRE, Professor AP-HP (Hôpital Necker)
Study Chair: Michèle KESSLER, Professor CHU Nancy
Study Chair: Emmanuel MORELON, Professor CHU Lyon
Study Chair: Sameh DAOUD, Doctor CHU Lyon
Study Chair: Cécile CHAUVET, Doctor CHU Lyon
Study Chair: Olivier THAUNAT, Doctor CHU Lyon
Study Chair: Jean-François SUBRA, Professor University Hospital, Angers
Study Chair: François BAYLE, Doctor CHU Grenoble
Study Chair: Elisabeth CASSUTO, Doctor CHU Nice
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00746057     History of Changes
Other Study ID Numbers: 06/2-E
Study First Received: September 2, 2008
Last Updated: May 23, 2011
Health Authority: France: Direction Générale de la Santé

Keywords provided by Nantes University Hospital:
Renal graft
chronic rejection
tolerance
DNA chip
biopsy

ClinicalTrials.gov processed this record on June 18, 2013