De Novo Transplant Disease
Conditions
Keywords
Renal, Transplantation, Tacrolimus, Arterial stiffness, Vascular fibrose plasma markers
Brief 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.
Interventions
Sponsors
Astellas Pharma Inc
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aorta stiffness at one year post-tranplantation | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 12 months | 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. |
| Endothelial activation at one year post-tranplantation | 12 months | 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. |
Countries
France
Contacts
Primary ContactRobinson JOANNIDES
Backup ContactMélissa DELHOMMEAU
Outcome results
None listed