Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE)

De Novo Transplant Disease Clinical Trial

— ADEQUATEartère  

Official title:

Effect of Advagraf on Arterial Stiffness and on Vascular Fibrosis Plasma Markers on de Novo Renal Transplant Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02154854
• Other study ID #: PHAO2011/YL/ADEQUATE-A
• Secondary ID: 2011-003184-29
• Status: Recruiting
• Phase: Phase 4
• First received: May 27, 2014
• Last updated: May 30, 2014
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2014
• Source: University Hospital, Tours
• Contact: Robinson JOANNIDES
• Email: Robinson.Joannides[@]chu-rouen.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare parallel-group effects between 4 months and 12 months post-transplantation 2 values of target residual concentrations of Advagraf on vascular parameters in de novo renal transplant patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 18 et 70 years

• Patient accepting to give a written informed consent

• Recipients of a first renal allograft (deceased or living, non HLA identical donor with compatible ABO blood type)

• Randomized in the ADEQUATE study

• Patients must have at J112 +/- 3 days a stable renal function (MDRD 4) with an absence of DSA since transplantation.

• Negative T cross-match in cytotoxicity

• Tolerate a daily dose of MMF at 1g

Exclusion Criteria:

• Acute rejection during the first months

• Existence of a BK infection since M3

• Proteinuria/reatininuria ratio > 1g/g since M3

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• De Novo Transplant Disease

Intervention

Drug:
• Tacrolimus targeted half-dose

• Tacrolimus targeted plain dose

Locations

Country	Name	City	State
France	CHU de Amiens	Amiens
France	CHU de Angers	Angers
France	CHU de Caen	Caen
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	HEGP	Paris
France	Necker	Paris
France	CHU de Rennes	Rennes
France	CHU de Rouen	Rouen
France	CHU de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse
France	CHRU de Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Astellas Pharma Inc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aorta stiffness at one year post-tranplantation	Evaluate the aorta stiffness at 1 year post-renal transplantation and its evolution in patients who received a half reduction of their daily dose of Advagraf ® 4 months after transplantation compared with patients whose dose has not been divided.	12 months	Yes
Secondary	Blood pressure	Evaluate peripheral and central blood pressures, the impact of reflected pressure waves and coupling cardiocirculatory (on the functional plan) and evaluate endothelial activation, factors promoting the vascular fibrosis and oxidant stress level (on biological plan) at 1 year post-renal transplantation and their evolution in patients who received a hal reduction of their daily dose Advagraf ® to four months of the transplant when compared with patients whose dose was not divided.	12 months	Yes
Secondary	Endothelial activation at one year post-tranplantation	Evaluate peripheral and central blood pressures, the impact of reflected pressure waves and coupling cardiocirculatory (on the functional plan) and evaluate endothelial activation, factors promoting the vascular fibrosis and oxidant stress level (on biological plan) at 1 year post-renal transplantation and their evolution in patients who received a hal reduction of their daily dose Advagraf ® to four months of the transplant when compared with patients whose dose was not divided.	12 months	Yes