A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
- Registration Number
- NCT01279538
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of the study is to assess the Pharmacokinetics (PK),
pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Subject is a recipient of a de novo kidney transplant from a living or deceased donor
- 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
- Prior to randomization, subject will receive antibody induction therapy (e.g., thymoglobulin, basiliximab, daclizumab, OKT3, alemtuzumab)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received a single 30-minute matching placebo infusion on Study Day 1, followed by a 90-day follow-up period. ASKP1240 highest dose bleselumab Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. ASKP1240 low dose bleselumab Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. ASKP1240 high dose bleselumab Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. ASKP1240 lowest dose bleselumab Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period.
- Primary Outcome Measures
Name Time Method Pharmacokinetic assessment through analysis of blood samples Up to Day 90
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati - University Internal Medicine Associates
🇺🇸Cincinnati, Ohio, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
University of Illinois Medical Center
🇺🇸Chicago, Illinois, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Central Pennsylvania Transplant Associates
🇺🇸Harrisburg, Pennsylvania, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Beth Israel Deaconess Medical Center, The Transplant Institute
🇺🇸Boston, Massachusetts, 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
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States