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

This study is currently recruiting participants.
Verified September 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01234363
First received: July 26, 2010
Last updated: September 18, 2013
Last verified: September 2013
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of technical failures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Tolerance (assessed by a questionnaire) [ Time Frame: 3 months and 12 months after graft ] [ Designated as safety issue: Yes ]
  • Evolution of the elasticity of the transplant between 3 and 12 months after graft [ Time Frame: 3 months and 12 months after graft ] [ Designated as safety issue: No ]
  • Correlation between elasticity and arterial resistance index [ Time Frame: 3 months and 12 months after graft ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01234363     History of Changes
Other Study ID Numbers: 2009.590
Study First Received: July 26, 2010
Last Updated: September 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014