A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
NCT ID: NCT01279538
Last Updated: 2025-11-17
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
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2010-11-17
2012-01-23
Brief Summary
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pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ASKP1240 lowest dose
Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.
bleselumab
Intravenous (IV) infusion
ASKP1240 low dose
Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.
bleselumab
Intravenous (IV) infusion
ASKP1240 high dose
Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.
bleselumab
Intravenous (IV) infusion
ASKP1240 highest dose
Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.
bleselumab
Intravenous (IV) infusion
Placebo
Participants received a single 30-minute matching placebo infusion on Study Day 1, followed by a 90-day follow-up period.
Placebo
Intravenous (IV) infusion
Interventions
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bleselumab
Intravenous (IV) infusion
Placebo
Intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior to randomization, the subject has a post-transplant serum creatinine value that is at least 30% decreased from the pre-transplant value and requires no dialysis
* Female subject of child bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment or upon hospitalization and must agree to maintain effective birth control during the study
* All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agrees to no sperm donation until the end of the study, or for 90 days after the last dose of study drug, whichever is longer
* Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions
Exclusion Criteria
* Subject has previously received or is receiving an organ transplant other than a kidney
* Recipient has a positive T or B cell crossmatch
* Subject has ABO blood type incompatibility with their donor
* Subject has received intravenous immunoglobulin (IVIG) therapy in the 3 months prior to first dose of study drug
* Recipient or donor is known by medical history to be seropositive for human immunodeficiency virus (HIV)
* Subject had a thromboembolic event (e.g., myocardial infarction, cerebrovascular event, pulmonary embolus, deep vein thrombosis, peripheral arterial thromboembolic event) in the past 5 years or if the subject is on specific therapy for prophylaxis or treatment of such an event. Low dose aspirin (81 mg) therapy is not considered exclusionary. NOTE: A one-time event of arterio-venous (AV) fistula dialysis access thrombosis is not exclusionary. Subjects with recurrent AV fistula thrombosis or those on systemic medications to prevent reoccurrence are excluded
* Subject has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Subject has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
* Subject is concurrently participating in another drug study or has received an investigational drug up to 8 weeks (depending on medication) prior to transplant
* Subject has previously received ASKP1240 or participated in a study involving ASKP1240
* Subject has abnormal chest x-ray indicative of acute or chronic lung disease on a prior examination within 3 months prior to randomization
* Subject has abnormal electrocardiogram (ECG) considered as clinically significant on a prior examination within 3 months prior to randomization
* Subject has uncontrolled intercurrent illness, including, but not limited to ongoing or active infection, any clinically significant cardiac disease, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements
* Subject has received live or live attenuated virus vaccinations within the last 30 days prior to first dose of study drug
* Subject has a clinical condition which would not allow safe conduct and completion of the study
* Subject is pregnant or lactating
18 Years
65 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Stanford University Medical Center
Palo Alto, California, United States
California Institute of Renal Research
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
University of Illinois Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Beth Israel Deaconess Medical Center, The Transplant Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati - University Internal Medicine Associates
Cincinnati, Ohio, United States
Central Pennsylvania Transplant Associates
Harrisburg, Pennsylvania, United States
Methodist University Hospital
Memphis, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Vincenti F, Klintmalm G, Yang H, Ram Peddi V, Blahunka P, Conkle A, Santos V, Holman J. A randomized, phase 1b study of the pharmacokinetics, pharmacodynamics, safety, and tolerability of bleselumab, a fully human, anti-CD40 monoclonal antibody, in kidney transplantation. Am J Transplant. 2020 Jan;20(1):172-180. doi: 10.1111/ajt.15560. Epub 2019 Sep 9.
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-0103
Identifier Type: -
Identifier Source: org_study_id
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