Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE)
NCT ID: NCT02154854
Last Updated: 2014-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
104 participants
INTERVENTIONAL
2013-07-31
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
NCT02057484
Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)
NCT01744470
Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation
NCT01742624
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
NCT01339468
Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients
NCT01680952
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Tacrolimus targeted half-dose
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
Tacrolimus targeted plain dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tacrolimus targeted half-dose
Tacrolimus targeted plain dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Existence of a BK infection since M3
* Proteinuria/reatininuria ratio \> 1g/g since M3
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astellas Pharma Inc
INDUSTRY
University Hospital, Tours
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robinson JOANNIDES
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Amiens
Amiens, , France
CHU de Angers
Angers, , France
CHU de Caen
Caen, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
HEGP
Paris, , France
Necker
Paris, , France
CHU de Rennes
Rennes, , France
CHU de Rouen
Rouen, , France
CHU de Strasbourg
Strasbourg, , France
CHU de Toulouse
Toulouse, , France
CHRU de Tours
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Anne-Elisabeth HENG
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-003184-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PHAO2011/YL/ADEQUATE-A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.