Clinical Trials Logo
  1. Home
  2. Renal Transplant
  3. NCT01234363
  4. Details
NCT01234363 Clinical Trial

Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography

Renal Transplant Clinical Trial

— GREFE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01234363
Other study ID # 2009.590
Secondary ID
Status Recruiting
Phase N/A
First received July 26, 2010
Last updated September 18, 2013
Start date May 2010
Est. completion date September 2013

Study information
Verified date September 2013
Source Hospices Civils de Lyon
Contact ROUVIERE Olivier, Pr
Phone 472 11 09 51
Email olivier.rouviere@netcourrier.com
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Renal allograft performed less than 3 months before enrolment

Exclusion Criteria:

- Contra-indication to magnetic resonance imaging

- Contra-indication to biopsy

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 3 months and 12 months after graft No
Secondary Number of technical failures 12 months No
Secondary Tolerance (assessed by a questionnaire) 3 months and 12 months after graft Yes
Secondary Evolution of the elasticity of the transplant between 3 and 12 months after graft 3 months and 12 months after graft No
Secondary Correlation between elasticity and arterial resistance index 3 months and 12 months after graft No
See also
  Status Clinical Trial Phase
Completed NCT01220050 - Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism Phase 2
Completed NCT00820469 - Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab Phase 4
Completed NCT00239005 - Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation Phase 4
Completed NCT00270153 - The Use of ACE Inhibitors in the Early Renal Post-transplant Period Phase 1
Completed NCT02711826 - Treg Therapy in Subclinical Inflammation in Kidney Transplantation Phase 1/Phase 2
Completed NCT03837522 - Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies N/A
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT01256294 - Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients Phase 4
Suspended NCT01059292 - TIPE2 Associated With Kidney Transplant N/A
Completed NCT00547040 - Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
Suspended NCT03043339 - Characterization Of the Intestinal Microbiome Evolution After Kidney Transplant Donation or Receipt
Completed NCT02581644 - Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries N/A
Completed NCT01728012 - Long-term Cardiovascular Risk Following Successful Renal Transplantation N/A
Terminated NCT01011114 - Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant N/A
Completed NCT02117596 - Calcineurin Inhibitor Based Immunosuppression Withdrawal N/A
Completed NCT00555373 - Pediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression N/A
Recruiting NCT05156086 - Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients
Completed NCT01334333 - Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients Phase 4
Recruiting NCT03107858 - The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function Phase 2/Phase 3
Completed NCT00352547 - Influence of Genes on Sirolimus Metabolism in Patients With Kidney Transplantation N/A