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ClinicalTrials.gov ID

NCT02154854

Lead Sponsor

University Hospital, ToursOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

104Estimated

Last Update Posted

Jun 3, 2014Estimated

Start Date

Jul 2013

Primary Completion Date

Mar 2015Estimated

Completion Date

Mar 2015Estimated

Official Title

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

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.

• De Novo Transplant Disease

• Tacrolimus targeted half-dose
• Tacrolimus targeted plain dose

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University Hospital, ToursOTHER

Collaborators

Astellas Pharma IncINDUSTRY

JFSubra@chu-angers.fr

huraultdeligny-b@chu-caen.fr

eric.thervet@egp.aphp.fr

christophe.legendre@nck.aphp.fr

cecile.vigneau@chu-rennes.fr

isabelle.etienne@chu-rouen.fr

yvon.lebranchu@univ-tours.fr