A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients

This is a two-part study. Part 1 (Phase 2) will enroll approximately 18 subjects and
includes 3 doses of ASP8597 (low dose, high dose, highest dose). 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.

Inclusion Criteria:

- Subject is scheduled to receive a kidney transplant from a deceased donor meeting at
least one of the following 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:

- 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