CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
NCT ID: NCT02217410
Last Updated: 2021-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
59 participants
INTERVENTIONAL
2015-02-05
2017-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Regimen A
CFZ533 administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
CFZ533
Tacrolimus (Tac)
Mycophenolate mofetil (MMF)
Corticosteroids (CS)
Regimen B
CFZ533 administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction
CFZ533
Mycophenolate mofetil (MMF)
Corticosteroids (CS)
anti-IL2 Induction
Regimen C
Standard of care (SoC) \[concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction\]
Tacrolimus (Tac)
Mycophenolate mofetil (MMF)
Corticosteroids (CS)
anti-IL2 Induction
Interventions
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CFZ533
Tacrolimus (Tac)
Mycophenolate mofetil (MMF)
Corticosteroids (CS)
anti-IL2 Induction
Eligibility Criteria
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Inclusion Criteria
* Recipients of a kidney transplant from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
* Recipients of a kidney with a cold ischemia time (CIT) \< 30 hours.
Exclusion Criteria
* ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
* Subjects receiving a second kidney allograft, unless the first allograft was lost due to surgical complication.
* Subjects at high immunological risk for rejection
* Subjects at risk for tuberculosis (TB)
* Subject with severe systemic infections, current or within the two weeks prior to randomization/enrollment.
* Any additional contraindication to the use of tacrolimus or mycophenolate mofetil according to the national labeling information of these products (see local product label).
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Aurora, Colorado, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Ann Arbor, Michigan, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
Livingston, New Jersey, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Utrecht, The Netherlands, Netherlands
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
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CCFZ533X2201
Identifier Type: -
Identifier Source: org_study_id
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