Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE)
- Conditions
- De Novo Transplant Disease
- Interventions
- Registration Number
- NCT02154854
- Lead Sponsor
- University Hospital, Tours
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 104
- 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
- Acute rejection during the first months
- Existence of a BK infection since M3
- Proteinuria/reatininuria ratio > 1g/g since M3
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A - tacrolimus half-dose Tacrolimus targeted half-dose Immunosuppressive strategy with 50 % reduction of Advagraf® daily dose at M4 (randomization) and unchanged MMF dose. Targeted tacrolimus trough level are to be higher than 3 ng/mL . If the dose is not in adequation with the dispensable units, the prescribed dose will be the closest higher dose. Drug: Tacrolimus targeted half-dose Group B - tacrolimus unchanged dose Tacrolimus targeted plain dose Immunosuppressive strategy will remain identical after randomization (M4): unchanged Advagraf® and MMF doses. Targeted tacrolimus trough level are to be between 7 and 12 ng/mL Drug: Tacrolimus targeted plain dose
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (11)
CHU de Rouen
🇫🇷Rouen, France
CHU de Amiens
🇫🇷Amiens, France
CHU de Rennes
🇫🇷Rennes, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHU de Strasbourg
🇫🇷Strasbourg, France
CHU de Toulouse
🇫🇷Toulouse, France
CHU de Angers
🇫🇷Angers, France
CHU de Caen
🇫🇷Caen, France
Necker
🇫🇷Paris, France
CHRU de Tours
🇫🇷Tours, France
HEGP
🇫🇷Paris, France