Status:
TERMINATED
A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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.
Detailed Description
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). ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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)
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01442337
Start Date
December 1 2011
End Date
July 1 2013
Last Update
June 20 2014
Active Locations (19)
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1
St. Vincent Medical Center
Los Angeles, California, United States, 90057
2
Sharp Memorial
San Diego, California, United States, 92123
3
California Pacific Medical Center
San Francisco, California, United States, 94115
4
University of California at San Francisco
San Francisco, California, United States, 94143