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

University Hospital, Tours104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

De Novo Transplant Disease

Interventions

Tacrolimus targeted half-doseDRUG

Tacrolimus targeted plain doseDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (11)

CHU de Amiens

Amiens, France

RECRUITING

CHU de Angers

Angers, France

RECRUITING

CHU de Caen

Caen, France

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 12 months

Endothelial activation at one year post-tranplantation

Time frame: 12 months

Central Contacts

Robinson JOANNIDES

CONTACT

Robinson.Joannides@chu-rouen.fr

Mélissa DELHOMMEAU

CONTACT

m.delhommeau@chu-tours.fr

Data from ClinicalTrials.gov

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