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

Tracking Information

First Received Date ^ICMJE

July 26, 2010

Last Updated Date

November 3, 2010

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01234363 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography

Official Title ^ICMJE

Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Renal Transplant

Intervention ^ICMJE

Device: Magnetic Resonance Elastography, and Supersonic Shear Imaging

Magnetic Resonance Elastography, and Supersonic Shear Imaging

Study Arm (s)

Experimental: Magnetic Resonance Elastography, Supersonic Shear Imaging

Magnetic Resonance Elastography and Supersonic Shear Imaging

Intervention: Device: Magnetic Resonance Elastography, and Supersonic Shear Imaging

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Renal allograft performed less than 3 months before enrolment

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: ROUVIERE Olivier, Pr

472 11 09 51 ext +33

olivier.rouviere@netcourrier.com

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01234363

Other Study ID Numbers ^ICMJE

2009.590

Has Data Monitoring Committee

Yes

Responsible Party

Pr Olivier Rouvière, Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03

Study Sponsor ^ICMJE

Hospices Civils de Lyon

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

ROUVIERE Olivier, Pr

Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03

Information Provided By

Hospices Civils de Lyon

Verification Date

September 2010

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

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