Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01234363
First received: July 26, 2010
Last updated: November 3, 2010
Last verified: September 2010
History of Changes
  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:

U.S. FDA Resources

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: 40
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (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: Pr Olivier Rouvière, Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03
ClinicalTrials.gov Identifier: NCT01234363     History of Changes
Other Study ID Numbers: 2009.590
Study First Received: July 26, 2010
Last Updated: November 3, 2010
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 May 23, 2013