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

Primary Purpose

Renal Transplant

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic Resonance Elastography, and Supersonic Shear Imaging
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Transplant focused on measuring Renal allograft, kidney, fibrosis, elastography, elasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Renal allograft performed less than 3 months before enrolment

Exclusion Criteria:

  • Contra-indication to magnetic resonance imaging
  • Contra-indication to biopsy

Sites / Locations

  • Service de Radiologie, Pavillon P Radio, Hôpital Edouard HerriotRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic Resonance Elastography, Supersonic Shear Imaging

Arm Description

Magnetic Resonance Elastography and Supersonic Shear Imaging

Outcomes

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

Secondary Outcome Measures

Number of technical failures
Tolerance (assessed by a questionnaire)
Evolution of the elasticity of the transplant between 3 and 12 months after graft
Correlation between elasticity and arterial resistance index

Full Information

First Posted
July 26, 2010
Last Updated
September 18, 2013
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01234363
Brief Title
Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography
Acronym
GREFE
Official Title
Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Transplant
Keywords
Renal allograft, kidney, fibrosis, elastography, elasticity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Resonance Elastography, Supersonic Shear Imaging
Arm Type
Experimental
Arm Description
Magnetic Resonance Elastography and Supersonic Shear Imaging
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Elastography, and Supersonic Shear Imaging
Intervention Description
Magnetic Resonance Elastography, and Supersonic Shear Imaging
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of technical failures
Time Frame
12 months
Title
Tolerance (assessed by a questionnaire)
Time Frame
3 months and 12 months after graft
Title
Evolution of the elasticity of the transplant between 3 and 12 months after graft
Time Frame
3 months and 12 months after graft
Title
Correlation between elasticity and arterial resistance index
Time Frame
3 months and 12 months after graft

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Renal allograft performed less than 3 months before enrolment Exclusion Criteria: Contra-indication to magnetic resonance imaging Contra-indication to biopsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ROUVIERE Olivier, Pr
Phone
472 11 09 51
Ext
+33
Email
olivier.rouviere@netcourrier.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROUVIERE Olivier, Pr
Organizational Affiliation
Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROUVIERE Olivier, Pr
Phone
4 72 11 09 51
Ext
+33
Email
olivier.rouviere@netcourrier.com
First Name & Middle Initial & Last Name & Degree
ROUVIERE Olivier, Pr

12. IPD Sharing Statement

Learn more about this trial

Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography

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