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Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography (GREFE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234363
First Posted: November 4, 2010
Last Update Posted: September 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.

Condition Intervention
Renal Transplant Device: Magnetic Resonance Elastography, and Supersonic Shear Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Correlation between elasticity (as measured by elastography) and (a) Banff score for fibrosis, (b) glomerular filtration rate assessed by creatinine clearance, (c) glomerular filtration rate assessed by insulin clearance [ Time Frame: 3 months and 12 months after graft ]

Secondary Outcome Measures:
  • Number of technical failures [ Time Frame: 12 months ]
  • Tolerance (assessed by a questionnaire) [ Time Frame: 3 months and 12 months after graft ]
  • Evolution of the elasticity of the transplant between 3 and 12 months after graft [ Time Frame: 3 months and 12 months after graft ]
  • Correlation between elasticity and arterial resistance index [ Time Frame: 3 months and 12 months after graft ]

Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic Resonance Elastography, Supersonic Shear Imaging
Magnetic Resonance Elastography and Supersonic Shear Imaging
Device: Magnetic Resonance Elastography, and Supersonic Shear Imaging
Magnetic Resonance Elastography, and Supersonic Shear Imaging

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal allograft performed less than 3 months before enrolment

Exclusion Criteria:

  • Contra-indication to magnetic resonance imaging
  • Contra-indication to biopsy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234363


Contacts
Contact: ROUVIERE Olivier, Pr 472 11 09 51 ext +33 olivier.rouviere@netcourrier.com

Locations
France
Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot Recruiting
Lyon, France, 69437
Contact: ROUVIERE Olivier, Pr    4 72 11 09 51 ext +33    olivier.rouviere@netcourrier.com   
Principal Investigator: ROUVIERE Olivier, Pr         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: ROUVIERE Olivier, Pr Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01234363     History of Changes
Other Study ID Numbers: 2009.590
First Submitted: July 26, 2010
First Posted: November 4, 2010
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by Hospices Civils de Lyon:
Renal allograft
kidney
fibrosis
elastography
elasticity

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes