Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients
NCT ID: NCT00403416
Last Updated: 2020-12-17
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
PHASE1/PHASE2
215 participants
INTERVENTIONAL
2006-10-31
2008-05-31
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.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
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.
Mycophenolic Acid / tacrolimus
Mycophenolic Acid
AEB071 / tacrolimus arm 1
AEB071
AEB071 / tacrolimus arm 2
AEB071
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AEB071
Mycophenolic Acid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult recipients of a kidney transplant from a deceased or from a living donor
* Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.
Exclusion Criteria
* Patients or donors infected with hepatitis B or C, or with HIV.
* Patients with a history of cancer
* Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
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.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Francisco
San Francisco, California, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
QE II Health Sciences Center
Halifax, , Canada
Hopital Kremlin Bicetre
Le Kremlin-Bicêtre, , France
Hopital Hotel Dieu
Nantes, , France
Hopital Necker
Paris, , France
CHU de Rangueil
Toulouse, , France
Universitaetsklinik Charite
Berlin, , Germany
Klinikum der Humboldt Universitat Charite
Berlin, , Germany
Staedt. Krankenhaus Koeln-Merheim
Cologne, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Univ. - Klinikum Heidelberg
Heidelberg, , Germany
Az. Osp. Di Bologna Polici. S. Orsola - Malpighi
Bologna, , Italy
Azienda Opedaliera Careggi - Universita degli Studi
Florence, , Italy
Azienda Ospedaliera di Padova - Universita degli Studi
Padua, , Italy
Ciutat Santitaria I Univessitaria de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Complejo Hospitalario Carlos Haya
Málaga, , Spain
Hospital Doctor Peset
Valencia, , Spain
Universitatsspital Basel
Basel, , Switzerland
Inselspital Bern
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
University Hospital of Wales
Cardiff, , United Kingdom
Western Infirmary
Glasgow, , United Kingdom
Saint George's University of London
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CAEB071A2203 from the Novartis Clinical Trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAEB071A2203
Identifier Type: -
Identifier Source: org_study_id