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

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ClinicalTrials.gov Identifier: NCT02154854
Recruitment Status : Unknown
Verified May 2014 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
De Novo Transplant Disease Drug: Tacrolimus targeted half-dose Drug: Tacrolimus targeted plain dose Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Advagraf on Arterial Stiffness and on Vascular Fibrosis Plasma Markers on de Novo Renal Transplant Patients
Study Start Date : July 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Group A - tacrolimus 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

Drug: Tacrolimus targeted half-dose
Other Name: Advagraf®

Experimental: Group B - tacrolimus unchanged 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
Drug: Tacrolimus targeted plain dose
Other Name: Advagraf®




Primary Outcome Measures :
  1. Aorta stiffness at one year post-tranplantation [ Time Frame: 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 :
  1. Blood pressure [ Time Frame: 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.

  2. Endothelial activation at one year post-tranplantation [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154854


Contacts
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Contact: Robinson JOANNIDES Robinson.Joannides@chu-rouen.fr
Contact: Mélissa DELHOMMEAU m.delhommeau@chu-tours.fr

Locations
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France
CHU de Amiens Recruiting
Amiens, France
Contact: Pierre-François WESTEEL       westeel.pierre-francois@chu-amiens.fr   
Principal Investigator: Pierre-François WESTEEL         
CHU de Angers Recruiting
Angers, France
Contact: Jean-François SUBRA       JFSubra@chu-angers.fr   
CHU de Caen Recruiting
Caen, France
Contact: Bruno HURAULT DE LIGNY       huraultdeligny-b@chu-caen.fr   
Principal Investigator: Bruno HURAULT DE LIGNY         
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Anne-Elisabeth HENG         
Principal Investigator: Anne-Elisabeth HENG         
HEGP Recruiting
Paris, France
Contact: Eric THERVET       eric.thervet@egp.aphp.fr   
Principal Investigator: Eric THERVET         
Necker Recruiting
Paris, France
Contact: Christophe LEGENDRE       christophe.legendre@nck.aphp.fr   
Principal Investigator: Christophe LEGENDRE         
CHU de Rennes Recruiting
Rennes, France
Contact: Cécile VIGNEAU       cecile.vigneau@chu-rennes.fr   
Principal Investigator: Cécile VIGNEAU         
CHU de Rouen Recruiting
Rouen, France
Contact: Isabelle ETIENNE       isabelle.etienne@chu-rouen.fr   
Principal Investigator: Isabelle ETIENNE         
CHU de Strasbourg Recruiting
Strasbourg, France
Contact: Bruno MOULIN       moulin@unistra.fr   
Principal Investigator: Bruno MOULIN         
CHU de Toulouse Recruiting
Toulouse, France
Contact: Lionel ROSTAING       rostaing.l@chu-toulouse.fr   
Principal Investigator: Lionel ROSTAING         
CHRU de Tours Recruiting
Tours, France
Contact: Yvon LEBRANCHU       yvon.lebranchu@univ-tours.fr   
Principal Investigator: Yvon LEBRANCHU         
Sponsors and Collaborators
University Hospital, Tours
Astellas Pharma Inc
Investigators
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Principal Investigator: Robinson JOANNIDES CHU de ROUEN

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02154854    
Other Study ID Numbers: PHAO2011/YL/ADEQUATE-A
2011-003184-29 ( EudraCT Number )
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014
Keywords provided by University Hospital, Tours:
Renal
Transplantation
Tacrolimus
Arterial stiffness
Vascular fibrose plasma markers
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action