The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.
This is a two-part study. Part 1 (Phase 2) has completed enrollment. Subjects are currently being followed per protocol. Data from Part 1 will be used to determine the doses used in Part 2 (Phase 3). Part 2 will enroll approximately 573 subjects and is planned to have 2 doses of ASP8597 (low dose and either the high or highest dose) along with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
21
St. Vincent Medical Center
Los Angeles, California, United States
Sharp Memorial
San Diego, California, United States
Pharmacokinetic (PK) variable for ASP8597: Maximum concentration (Cmax)
Part 1 PK variable
Time frame: 3 days
Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Part 1 PK variable
Time frame: 3 days
Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to infinity (AUCinf)
Part 1 PK variable
Time frame: 3 days
Estimated glomerular filtration rate (eGFR) using abbreviated Modified Diet in Renal Disease (MDRD) formula - Part 2
Part 2 efficacy variable
Time frame: 12 months
Pharmacokinetic variable for ASP8597: Time to attain Cmax (Tmax)
Part 1 PK variable
Time frame: 3 days
Pharmacokinetic variable for ASP8597: Clearance (CL)
Part 1 PK variable
Time frame: 3 days
Pharmacokinetic variable for ASP8597: Volume of Distribution (Vz)
Part 1 PK variable
Time frame: 3 days
Pharmacokinetic variable for ASP8597: Apparent terminal elimination half-life (t1/2)
Part 1 PK variable
Time frame: 3 days
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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
...and 9 more locations
Requirement of dialysis within the first 7 days post transplant - Part 1
Part 1 efficacy variable
Time frame: 7 days
eGFR using abbreviated MDRD formula - Part 1
Part 1 efficacy variable
Time frame: 12 months
Requirement of dialysis within the first 7 days post transplant - Part 2
Part 2 efficacy variable
Time frame: 7 days
Patient survival
Part 2 efficacy variable
Time frame: 12 months
Graft survival
Part 2 efficacy variable
Time frame: 12 months
Biopsy-proven acute rejection (BPAR)
Part 2 efficacy variable
Time frame: 12 Months
Clinically treated rejection
Subjects who receive immunosuppressive medications for the treatment of suspected or biopsy-proven acute rejection. Part 2 efficacy variable
Time frame: 12 months