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

July 26, 2010
September 18, 2013
May 2010
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01234363 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography
Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant

The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Renal Transplant
Device: Magnetic Resonance Elastography, and Supersonic Shear Imaging
Magnetic Resonance Elastography, and Supersonic Shear Imaging
Experimental: Magnetic Resonance Elastography, Supersonic Shear Imaging
Magnetic Resonance Elastography and Supersonic Shear Imaging
Intervention: Device: Magnetic Resonance Elastography, and Supersonic Shear Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Renal allograft performed less than 3 months before enrolment

Exclusion Criteria:

  • Contra-indication to magnetic resonance imaging
  • Contra-indication to biopsy
Both
18 Years and older
No
Contact: ROUVIERE Olivier, Pr 472 11 09 51 ext +33 olivier.rouviere@netcourrier.com
France
 
NCT01234363
2009.590
Yes
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: ROUVIERE Olivier, Pr Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03
Hospices Civils de Lyon
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP