Study Stopped
Study was terminated by sponsor decision
A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients
A Phase 2/3, Double-Blind, Placebo-Controlled, Two-Part Study (Part 1 Open-Label) to Assess the Safety, Efficacy and Pharmacokinetics of Single Intravenous Doses of ASP8597 (Diannexin) in de Novo Kidney Transplant Recipients
1 other identifier
interventional
21
1 country
19
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2011
19 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
September 16, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJune 20, 2014
June 1, 2014
1.6 years
September 16, 2011
June 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pharmacokinetic (PK) variable for ASP8597: Maximum concentration (Cmax)
Part 1 PK variable
3 days
Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Part 1 PK variable
3 days
Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to infinity (AUCinf)
Part 1 PK variable
3 days
Estimated glomerular filtration rate (eGFR) using abbreviated Modified Diet in Renal Disease (MDRD) formula - Part 2
Part 2 efficacy variable
12 months
Secondary Outcomes (11)
Pharmacokinetic variable for ASP8597: Time to attain Cmax (Tmax)
3 days
Pharmacokinetic variable for ASP8597: Clearance (CL)
3 days
Pharmacokinetic variable for ASP8597: Volume of Distribution (Vz)
3 days
Pharmacokinetic variable for ASP8597: Apparent terminal elimination half-life (t1/2)
3 days
Requirement of dialysis within the first 7 days post transplant - Part 1
7 days
- +6 more secondary outcomes
Study Arms (4)
ASP8597 low dose
EXPERIMENTALASP8597 high dose
EXPERIMENTALASP8597 highest dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORPlacebo comparator used in Part 2 only
Interventions
Eligibility Criteria
You may qualify if:
- Subject is scheduled to receive a kidney transplant from a deceased donor meeting at least one of the following criteria:
- 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:
- Donor died of a cerebral bleed
- Donor had a history of hypertension
- Donor's terminal serum creatinine concentration was \> 1.5 mg/dL
- Donation after Cardiac Death (DCD) - Donor was pronounced dead prior to procurement of the kidney
- 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
- 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
You may not qualify if:
- Female subject is pregnant or lactating
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
St. Vincent Medical Center
Los Angeles, California, 90057, United States
Sharp Memorial
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of California at San Francisco
San Francisco, California, 94143, United States
University of Colorado
Aurora, Colorado, 80045, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University
St Louis, Missouri, 63110, United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039, United States
New York Presbyterian Hospital
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, 17011, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Baylor All Saints Medical Center
Fort Worth, Texas, 76104, United States
The Methodist Hospital
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2011
First Posted
September 28, 2011
Study Start
December 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
June 20, 2014
Record last verified: 2014-06