A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
1 other identifier
interventional
149
1 country
42
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids \[calcineurin inhibitor (CNI) avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids \[CNI minimization-MMF avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2013
Typical duration for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2013
CompletedFirst Posted
Study publicly available on registry
January 31, 2013
CompletedStudy Start
First participant enrolled
March 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2017
CompletedNovember 21, 2025
November 1, 2025
1.3 years
January 29, 2013
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review
6 months
Secondary Outcomes (3)
Glomerular Filtration Rate (GFR)
6 months
Patient Survival
6 months
Graft Survival
6 months
Study Arms (3)
Standard of Care
ACTIVE COMPARATORBasiliximab induction + Tacrolimus + MMF + Corticosteroids
CNI avoidance
EXPERIMENTALBasiliximab induction + ASKP1240 + MMF + Corticosteroids
CNI minimization-MMF avoidance
EXPERIMENTALBasiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids
Interventions
intravenous or oral
intravenous or oral
intravenous
Eligibility Criteria
You may qualify if:
- Subject is a recipient of a de novo kidney from a living or deceased donor
You may not qualify if:
- Subject has induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen
- 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 an ABO incompatible donor kidney
- Subject has a current calculated panel reactive antibody (cPRA) level \>50%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Global Development, Inc.lead
- Kyowa Kirin Co., Ltd.collaborator
Study Sites (42)
Site US10006
Birmingham, Alabama, 35233, United States
Site US10024
Phoenix, Arizona, 85054, United States
Site US10008
Los Angeles, California, 90057, United States
Site US10021
Palo Alto, California, 94304, United States
Site US10030
San Diego, California, 92123, United States
Site US10004
San Francisco, California, 94115, United States
Site US10003
San Francisco, California, 94143, United States
Site US10013
Aurora, Colorado, 80045, United States
Site US10007
Atlanta, Georgia, 30322, United States
Site US10041
Augusta, Georgia, 30912, United States
Site US10010
Chicago, Illinois, 60612, United States
Site US10018
Chicago, Illinois, 60612, United States
Site US10037
Chicago, Illinois, 60637, United States
Site US10015
Lexington, Kentucky, 40536, United States
Site US10045
New Orleans, Louisiana, 70112, United States
Site US10014
Baltimore, Maryland, 21201, United States
Site US10017
Ann Arbor, Michigan, 48109, United States
Site US10025
St Louis, Missouri, 63110, United States
Site US10022
Livingston, New Jersey, 07039, United States
Site US10031
Buffalo, New York, 14215, United States
Site US10034
New York, New York, 10029, United States
Site US10023
New York, New York, 10065, United States
Site US10019
The Bronx, New York, 10467, United States
Site US10036
Chapel Hill, North Carolina, 27599, United States
Site US10042
Charlotte, North Carolina, 28203, United States
Site US10016
Durham, North Carolina, 27710, United States
Site US10026
Greenville, North Carolina, 27834, United States
Site US10009
Cincinnati, Ohio, 45267, United States
Site US10040
Cleveland, Ohio, 44106, United States
Site US10032
Cleveland, Ohio, 44195, United States
Site US10027
Harrisburg, Pennsylvania, 17011, United States
Site US10038
Pittsburgh, Pennsylvania, 15213, United States
Site US10012
Charleston, South Carolina, 29425, United States
Site US10028
Memphis, Tennessee, 38104, United States
Site US10035
Nashville, Tennessee, 37232-4750, United States
Site US10001
Dallas, Texas, 75246, United States
Site US10002
Fort Worth, Texas, 76104, United States
Site US10029
Houston, Texas, 77030, United States
Site US10044
Houston, Texas, 77030, United States
Site US10033
Salt Lake City, Utah, 84132, United States
Site US10020
Charlottesville, Virginia, 22908, United States
Site US10005
Madison, Wisconsin, 53792, United States
Related Publications (1)
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.
PMID: 31509331DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2013
First Posted
January 31, 2013
Study Start
March 5, 2013
Primary Completion
June 30, 2014
Study Completion
January 27, 2017
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency.