- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154854
Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE) (ADEQUATEartère)
May 30, 2014 updated by: University Hospital, Tours
Effect of Advagraf on Arterial Stiffness and on Vascular Fibrosis Plasma Markers on de Novo Renal Transplant Patients
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
104
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Robinson JOANNIDES
- Email: Robinson.Joannides@chu-rouen.fr
Study Contact Backup
- Name: Mélissa DELHOMMEAU
- Email: m.delhommeau@chu-tours.fr
Study Locations
-
-
-
Amiens, France
- Recruiting
- CHU de Amiens
-
Contact:
- Pierre-François WESTEEL
- Email: westeel.pierre-francois@chu-amiens.fr
-
Principal Investigator:
- Pierre-François WESTEEL
-
Angers, France
- Recruiting
- CHU de Angers
-
Contact:
- Jean-François SUBRA
- Email: JFSubra@chu-angers.fr
-
Caen, France
- Recruiting
- CHU de Caen
-
Contact:
- Bruno HURAULT DE LIGNY
- Email: huraultdeligny-b@chu-caen.fr
-
Principal Investigator:
- Bruno HURAULT DE LIGNY
-
Clermont-Ferrand, France, 63003
- Recruiting
- CHU de Clermont-Ferrand
-
Principal Investigator:
- Anne-Elisabeth HENG
-
Paris, France
- Recruiting
- HEGP
-
Principal Investigator:
- Eric THERVET
-
Contact:
- Eric THERVET
- Email: eric.thervet@egp.aphp.fr
-
Paris, France
- Recruiting
- NECKER
-
Contact:
- Christophe LEGENDRE
- Email: christophe.legendre@nck.aphp.fr
-
Principal Investigator:
- Christophe LEGENDRE
-
Rennes, France
- Recruiting
- CHU de Rennes
-
Contact:
- Cécile VIGNEAU
- Email: cecile.vigneau@chu-rennes.fr
-
Principal Investigator:
- Cécile VIGNEAU
-
Rouen, France
- Recruiting
- CHU de Rouen
-
Contact:
- Isabelle ETIENNE
- Email: isabelle.etienne@chu-rouen.fr
-
Principal Investigator:
- Isabelle ETIENNE
-
Strasbourg, France
- Recruiting
- CHU de Strasbourg
-
Principal Investigator:
- Bruno MOULIN
-
Contact:
- Bruno MOULIN
- Email: moulin@unistra.fr
-
Toulouse, France
- Recruiting
- CHU de Toulouse
-
Principal Investigator:
- Lionel Rostaing
-
Contact:
- Lionel ROSTAING
- Email: rostaing.l@chu-toulouse.fr
-
Tours, France
- Recruiting
- CHRU de Tours
-
Principal Investigator:
- Yvon LEBRANCHU
-
Contact:
- Yvon LEBRANCHU
- Email: yvon.lebranchu@univ-tours.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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 |
Other Names:
|
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
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robinson JOANNIDES, CHU de Rouen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Anticipated)
March 1, 2015
Study Completion (Anticipated)
March 1, 2015
Study Registration Dates
First Submitted
May 27, 2014
First Submitted That Met QC Criteria
May 30, 2014
First Posted (Estimate)
June 3, 2014
Study Record Updates
Last Update Posted (Estimate)
June 3, 2014
Last Update Submitted That Met QC Criteria
May 30, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHAO2011/YL/ADEQUATE-A
- 2011-003184-29 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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