A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation
NCT ID: NCT00817687
Last Updated: 2012-07-09
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.
COMPLETED
PHASE4
66 participants
INTERVENTIONAL
2009-01-31
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
mycophenolate mofetil [CellCept]
As prescribed; + early biopsy
2
mycophenolate mofetil [CellCept]
As prescribed; + standard treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mycophenolate mofetil [CellCept]
As prescribed; + early biopsy
mycophenolate mofetil [CellCept]
As prescribed; + standard treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* in receipt of an initial cadaveric kidney transplant;
* in receipt of graft with biopsy;
* in receipt of a 'marginal' kidney transplant.
Exclusion Criteria
* in receipt of a multi-organ transplant or a double kidney transplant;
* malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix;
* replicating hepatitis B and/or C, or HIV positive serology.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
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.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Besançon, , France
Bordeaux, , France
Caen, , France
Clermont-Ferrand, , France
Lille, , France
Limoges, , France
Marseille, , France
Nantes, , France
Paris, , France
Paris, , France
Poitiers, , France
Rouen, , France
Salouël, , France
Strasbourg, , France
Suresnes, , France
Tours, , France
Vandœuvre-lès-Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML21655
Identifier Type: -
Identifier Source: org_study_id