De Novo Transplant DiseasePhase 4ADEQUATEartèreNCT02154854
Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE)
A Phase 4 study testing Tacrolimus targeted half-dose and Tacrolimus targeted plain dose in people with De Novo Transplant Disease, run by University Hospital, Tours at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- De Novo Transplant Disease
- What is being tested?
- Tacrolimus targeted half-dose and Tacrolimus targeted plain dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 11 sitesFrance
- Study dates
- Jul 2013to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute rejection during the first months
- Existence of a BK infection since M3
- Proteinuria/reatininuria ratio > 1g/g since M3
Trial locations and contacts
11 sites in 1 country.
Robinson JOANNIDES contact
Mélissa DELHOMMEAU contact
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CHU de Amiens
Amiens
Pierre-François WESTEEL, westeel.pierre-francois@chu-amiens.fr
Pierre-François WESTEEL
- Recruiting
CHU de Angers
Angers
Jean-François SUBRA, JFSubra@chu-angers.fr
- Recruiting
CHU de Caen
Caen
Bruno HURAULT DE LIGNY, huraultdeligny-b@chu-caen.fr
Bruno HURAULT DE LIGNY
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Anne-Elisabeth HENG
Anne-Elisabeth HENG
- Recruiting
HEGP
Paris
Eric THERVET, eric.thervet@egp.aphp.fr
Eric THERVET
- Recruiting
Necker
Paris
Christophe LEGENDRE, christophe.legendre@nck.aphp.fr
Christophe LEGENDRE
- Recruiting
CHU de Rennes
Rennes
Cécile VIGNEAU, cecile.vigneau@chu-rennes.fr
Cécile VIGNEAU
- Recruiting
CHU de Rouen
Rouen
Isabelle ETIENNE, isabelle.etienne@chu-rouen.fr
Isabelle ETIENNE
- Recruiting
CHU de Strasbourg
Strasbourg
Bruno MOULIN, moulin@unistra.fr
Bruno MOULIN
- Recruiting
CHU de Toulouse
Toulouse
Lionel ROSTAING, rostaing.l@chu-toulouse.fr
Lionel ROSTAING
- Recruiting
CHRU de Tours
Tours
Yvon LEBRANCHU, yvon.lebranchu@univ-tours.fr
Yvon LEBRANCHU
About this study
Official title: 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.
- Conditions
- De Novo Transplant Disease
- Being tested
- Tacrolimus targeted half-dose, Tacrolimus targeted plain dose
- Keywords
- Renal, Transplantation, Tacrolimus, Arterial stiffness, Vascular fibrose plasma markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus targeted half-doseDrug
Also called Advagraf®
Tacrolimus targeted plain doseDrug
Also called Advagraf®
| Study group | Role | What they receive |
|---|---|---|
| Group A - tacrolimus half-dose | Experimental | 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 Receives: Drug: Tacrolimus targeted half-dose |
| Group B - tacrolimus unchanged dose | Experimental | 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 Receives: Drug: Tacrolimus targeted plain dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
Endothelial activation at one year post-tranplantation
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJul 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Novo Transplant DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Robinson JOANNIDES, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154854
- Sponsor's protocol ID
- PHAO2011/YL/ADEQUATE-A
- Other IDs
- 2011-003184-29
- Acronym
- ADEQUATEartère
- Status last verified
- May 2014
- First submitted
- 27 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Advagraf on Arterial Stiffness and on Vascular Fibrosis Plasma Markers on de Novo Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT02154854
- Acronym / sponsor ID
- ADEQUATEartère / PHAO2011/YL/ADEQUATE-A
- Conditions
- De Novo Transplant Disease
- Keywords
- Renal, Transplantation, Tacrolimus, Arterial stiffness, Vascular fibrose plasma markers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - tacrolimus half-dose | Experimental | Drug: Tacrolimus targeted half-doseImmunosuppressive 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 |
| Group B - tacrolimus unchanged dose | Experimental | Drug: Tacrolimus targeted plain doseImmunosuppressive 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Acute rejection during the first months
- Existence of a BK infection since M3
- Proteinuria/reatininuria ratio > 1g/g since M3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus targeted half-doseAlso: Advagraf® | Drug | Group A - tacrolimus half-dose |
| Tacrolimus targeted plain doseAlso: Advagraf® | Drug | Group B - tacrolimus unchanged dose |
Primary outcome
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.
2 secondary outcomes
Blood pressure
Time frame: 12 months
Endothelial activation at one year post-tranplantation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robinson JOANNIDES contact
Mélissa DELHOMMEAU contact
Robinson JOANNIDES principal investigator
University Hospital, Rouen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus targeted half-dose and Tacrolimus targeted plain dose in people with De Novo Transplant Disease, run by University Hospital, Tours at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robinson JOANNIDES (Robinson.Joannides@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aorta stiffness at one year post-tranplantation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.