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

Hospices Civils de Lyon1 site in 1 country60 target enrollmentMay 2010

ConditionsRenal Transplant

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Renal Transplant
Sponsor: Hospices Civils de Lyon
Enrollment: 60
Locations: 1
Primary Endpoint: 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
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

September 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

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