A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
NCT ID: NCT01780844
Last Updated: 2025-11-21
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
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COMPLETED
PHASE2
149 participants
INTERVENTIONAL
2013-03-05
2017-01-27
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
TREATMENT
NONE
Study Groups
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Standard of Care
Basiliximab induction + Tacrolimus + MMF + Corticosteroids
Tacrolimus
intravenous or oral
Mycophenolate Mofetil (MMF)
intravenous or oral
Basiliximab
intravenous
Methylprednisone
Intravenous
Prednisone
Oral
CNI avoidance
Basiliximab induction + ASKP1240 + MMF + Corticosteroids
ASKP1240
intravenous infusion
Mycophenolate Mofetil (MMF)
intravenous or oral
Basiliximab
intravenous
Methylprednisone
Intravenous
Prednisone
Oral
CNI minimization-MMF avoidance
Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids
ASKP1240
intravenous infusion
Tacrolimus
intravenous or oral
Basiliximab
intravenous
Methylprednisone
Intravenous
Prednisone
Oral
Interventions
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ASKP1240
intravenous infusion
Tacrolimus
intravenous or oral
Mycophenolate Mofetil (MMF)
intravenous or oral
Basiliximab
intravenous
Methylprednisone
Intravenous
Prednisone
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject has previously received or is receiving an organ transplant other than a kidney
* Subject will receive a solitary kidney from a deceased donor \< 5 years of age
* Subject will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours
* Subject will receive a kidney that meets both Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. Note: a kidney that meets either ECD or DCD criteria is eligible for inclusion
* Subject will receive an ABO incompatible donor kidney
* Subject has a current calculated panel reactive antibody (cPRA) level \>50%
18 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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Site US10006
Birmingham, Alabama, United States
Site US10024
Phoenix, Arizona, United States
Site US10008
Los Angeles, California, United States
Site US10021
Palo Alto, California, United States
Site US10030
San Diego, California, United States
Site US10004
San Francisco, California, United States
Site US10003
San Francisco, California, United States
Site US10013
Aurora, Colorado, United States
Site US10007
Atlanta, Georgia, United States
Site US10041
Augusta, Georgia, United States
Site US10010
Chicago, Illinois, United States
Site US10018
Chicago, Illinois, United States
Site US10037
Chicago, Illinois, United States
Site US10015
Lexington, Kentucky, United States
Site US10045
New Orleans, Louisiana, United States
Site US10014
Baltimore, Maryland, United States
Site US10017
Ann Arbor, Michigan, United States
Site US10025
St Louis, Missouri, United States
Site US10022
Livingston, New Jersey, United States
Site US10031
Buffalo, New York, United States
Site US10034
New York, New York, United States
Site US10023
New York, New York, United States
Site US10019
The Bronx, New York, United States
Site US10036
Chapel Hill, North Carolina, United States
Site US10042
Charlotte, North Carolina, United States
Site US10016
Durham, North Carolina, United States
Site US10026
Greenville, North Carolina, United States
Site US10009
Cincinnati, Ohio, United States
Site US10040
Cleveland, Ohio, United States
Site US10032
Cleveland, Ohio, United States
Site US10027
Harrisburg, Pennsylvania, United States
Site US10038
Pittsburgh, Pennsylvania, United States
Site US10012
Charleston, South Carolina, United States
Site US10028
Memphis, Tennessee, United States
Site US10035
Nashville, Tennessee, United States
Site US10001
Dallas, Texas, United States
Site US10002
Fort Worth, Texas, United States
Site US10029
Houston, Texas, United States
Site US10044
Houston, Texas, United States
Site US10033
Salt Lake City, Utah, United States
Site US10020
Charlottesville, Virginia, United States
Site US10005
Madison, Wisconsin, United States
Countries
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References
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Harland RC, Klintmalm G, Jensik S, Yang H, Bromberg J, Holman J, Kumar MSA, Santos V, Larson TJ, Wang X. Efficacy and safety of bleselumab in kidney transplant recipients: A phase 2, randomized, open-label, noninferiority study. Am J Transplant. 2020 Jan;20(1):159-171. doi: 10.1111/ajt.15591. Epub 2019 Oct 19.
Related Links
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Link to results and other applicable study documents on the Astellas Clinical Trials website
Link to plain language summary of the study on the Trial Results Summaries website
Other Identifiers
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7163-CL-0108
Identifier Type: -
Identifier Source: org_study_id
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