A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients
NCT ID: NCT01442337
Last Updated: 2014-06-20
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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TERMINATED
PHASE2/PHASE3
21 participants
INTERVENTIONAL
2011-12-31
2013-07-31
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
PREVENTION
QUADRUPLE
Study Groups
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ASP8597 low dose
ASP8597
one time IV dose
ASP8597 high dose
ASP8597
one time IV dose
ASP8597 highest dose
ASP8597
one time IV dose
Placebo
Placebo comparator used in Part 2 only
Placebo
one time IV dose
Interventions
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ASP8597
one time IV dose
Placebo
one time IV dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Expanded Criteria Donor (ECD)
* i Donor was \> 60 years of age, OR
* ii. Donor was 50-59 years of age, inclusive, and met at least two of the following criteria:
1. Donor died of a cerebral bleed
2. Donor had a history of hypertension
3. Donor's terminal serum creatinine concentration was \> 1.5 mg/dL
2. Donation after Cardiac Death (DCD) - Donor was pronounced dead prior to procurement of the kidney
3. Standard Criteria Donor (SCD)
* i. Donor with terminal serum creatinine \< 1.5 mg/dL where kidney is anticipated to have a minimum of 24 hours of cold ischemia prior to transplantation, OR
* ii. Donor with terminal serum creatinine \> 1.5 mg/dL and any cold ischemic time up to exclusion limit
* Female subject is not pregnant and agrees to use an acceptable form of contraception throughout study
* Male subject agrees to use an adequate method of contraception and agrees to no sperm donation throughout the study
Exclusion Criteria
* Donor kidney is anticipated to have more than 40 hours of cold ischemia time
* Donor is \> 66 years of age
* Donor meets both DCD and ECD criteria
* Subject has previously received, or is receiving an organ transplant other than a kidney
* Subject has a positive T or B cell crossmatch by the investigational site's standard method of determination. For recipients where only a flow cytometry crossmatch is performed and is positive in either T or B cell testing, recipients are excluded only if donor specific, anti-HLA antibody is detected by flow cytometry based, specific anti-HLA antibody testing
* Subject has ABO blood type incompatibility with his/her organ donor
* Recipient or donor is known by medical history to be seropositive for human immunodeficiency virus (HIV)
* Subject has a known bleeding diathesis
* Subject has a International Normalized Ratio (INR) \> 1.5 times upper limit of normal at Screening
* Subject has a platelet count \< 100,000 platelets/µL at Screening
* Subject used anti-platelet agents \[e.g., Plavix® (clopidogrel bisulfate), Brilinta® (ticagrelor)\] (with the exception of aspirin \< 100 mg/day for cardiovascular prophylaxis), anti-coagulants \[e.g., Pradaxa® (dabigatran), Xarelto® (rivaroxaban)\], anti-thrombotics, and/or blood-thinning agents within the 10 days prior to Screening; and/or subject is expected to require use of any of these agents during the first 15 days of the study period (with the exception of standard of care peri-operative administration of heparin for DVT prophylaxis)
* Subject has an uncontrolled concomitant infection
* 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 currently is participating in an investigational drug study, or participated in an investigational drug study within the last 30 days)
* Subject has a history of or is believed to have used an illicit drug(s) and/or abused alcohol within the last 3 months
* Subject has an unstable psychiatric illness
* Subject has previously received ASP8597 or participated in a study involving ASP8597
18 Years
70 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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St. Vincent Medical Center
Los Angeles, California, United States
Sharp Memorial
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California at San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
New York Presbyterian Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
Baylor All Saints Medical Center
Fort Worth, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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8597-CL-0201
Identifier Type: -
Identifier Source: org_study_id
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