- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00555789
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients
December 11, 2020 updated by: Novartis Pharmaceuticals
A 24 Month Extension to a 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients
This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
137
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Halifax, Canada, B3H 1V7
- Novartis Investigative Site
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Le Kremlin Bicetre, France, 94270
- Novartis Investigative Site
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Nantes, France, 44035
- Novartis Investigative Site
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Paris, France, 75015
- Novartis Investigative Site
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Toulouse, France, 31403
- Novartis Investigative Site
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Berlin, Germany, 13353
- Novartis Investigative Site
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Berlin, Germany
- Novartis Investigative Site
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Essen, Germany, 45122
- Novartis Investigative Site
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Hannover, Germany, 30625
- Novartis Investigative Site
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Heidelberg, Germany, 69120
- Novartis Investigative Site
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Koeln, Germany
- Novartis Investigative Site
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Bologna, Italy, 40138
- Novartis Investigative Site
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Firenze, Italy, 50134
- Novartis Investigative Site
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Padova, Italy, 35128
- Novartis Investigative Site
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Llobregat, Spain, 08907
- Novartis Investigative Site
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Madrid, Spain, 28041
- Novartis Investigative Site
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Malaga, Spain, 28041
- Novartis Investigative Site
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Valencia, Spain, 46017
- Novartis Investigative Site
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Basel, Switzerland, 4031
- Novartis Investigative Site
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Bern, Switzerland, 3010
- Novartis Investigative Site
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Zürich, Switzerland, 8091
- Novartis Investigative Site
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Cardiff, United Kingdom, CF14 4XW
- Novartis Investigative Site
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Glasgow, United Kingdom, G11 6NT
- Novartis Investigative Site
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London, United Kingdom
- Novartis Investigative Site
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Manchester, United Kingdom
- Novartis Investigative Site
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California
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San Francisco, California, United States, 94143-0780
- Novartis Investigative Site
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Wisconsin
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Madison, Wisconsin, United States, 53706
- Novartis Investigative Site
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Participation in core study CAEB071A2203
- The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit.
- Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).
Exclusion criteria:
- Pregnancy. Other protocol-defined inclusion/exclusion criteria may apply
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 1
mycophenolic and tacrolimus
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720mg b.i.d. 2yrs
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Experimental: 2
mycophenolic and tacrolimus
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200mg oral b.i.d.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months.
Time Frame: three Yrs
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three Yrs
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Efficacy assessed by: the incidence over 36 months of the composite endpoint of biopsy proven rejection ≥ 1A, graft loss, death, or loss to follow-up in the two study arms.
Time Frame: Three yrs
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Three yrs
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
November 8, 2007
First Submitted That Met QC Criteria
November 8, 2007
First Posted (Estimate)
November 9, 2007
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 11, 2020
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEB071A2203E1
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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Astellas Pharma IncAstellas Pharma Europe B.V.CompletedKidney Transplantation | Renal Transplantation | Transplantation, Kidney | Grafting, Kidney | Transplantation, RenalBelgium, Germany, Spain, Sweden, Italy, Switzerland, United Kingdom, Austria, France, Poland, Czech Republic, Netherlands
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Bristol-Myers SquibbCompletedKidney Transplantation: Transplantation, Kidney
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Nantes University HospitalTerminated
-
Hospices Civils de LyonCompletedKidney Transplantation | Pancreas-kidney TransplantationFrance
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCzechia, France, Italy, Poland, United Kingdom
-
The Hospital for Sick ChildrenCompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCanada
-
Astellas Pharma Europe Ltd.TerminatedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationSpain, Australia, France, Germany, Canada, Italy, United Kingdom, Belgium, South Africa, Switzerland, Sweden, United States, Austria, Brazil, Czechia, Denmark, Finland, Hungary, Ireland, Mexico, Netherlands, New Zealand, Poland
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
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Medical University of ViennaUnknownKidney Function After Transplantation | Outcome After Kidney Transplantation
Clinical Trials on mycophenolic plus tacrolimus
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Novartis PharmaceuticalsCompletedRenal TransplantationUnited States, Germany, United Kingdom, Belgium, Australia, Hungary, Netherlands, Sweden, Colombia, Argentina, Brazil, Canada, Denmark, Korea, Republic of, Portugal
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Assiut UniversityUnknownRejection Acute Renal
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Astellas Pharma China, Inc.Completed
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Translational Research Center for Medical Innovation...Kyoto UniversityCompleted
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University Medical Center GroningenAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Leiden University...CompletedRenal Insufficiency | Kidney TransplantationNetherlands
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Milton S. Hershey Medical CenterNovartis PharmaceuticalsCompletedRenal Failure | ImmunosuppressionUnited States
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Astellas Pharma Korea, Inc.Completedde Novo Kidney TransplantationKorea, Republic of
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Asan Medical CenterUnknown
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Imperial College Healthcare NHS TrustCompletedGlomerulonephritis, MembranousUnited Kingdom
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Hoffmann-La RocheCompleted