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

Regional University Hospital Center (CHRU)

Status and phase: Unknown; Phase 4

Conditions: De Novo Transplant Disease

Treatments: Drug: Tacrolimus targeted half-dose; Drug: Tacrolimus targeted plain dose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02154854

PHAO2011/YL/ADEQUATE-A

2011-003184-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Group A - tacrolimus half-dose

Experimental group

Description:

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

Treatment:

Drug: Tacrolimus targeted half-dose

Group B - tacrolimus unchanged dose

Experimental group

Description:

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

Treatment:

Drug: Tacrolimus targeted plain dose