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

Astellas

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: ASP8597; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01442337

8597-CL-0201

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.

Full 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). 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 4 patient groups, including a placebo group

ASP8597 low dose

Experimental group

Treatment:

Drug: ASP8597

ASP8597 high dose

Experimental group

Treatment:

Drug: ASP8597

ASP8597 highest dose

Experimental group

Treatment:

Drug: ASP8597

Placebo

Placebo Comparator group

Description:

Placebo comparator used in Part 2 only

Treatment:

Drug: Placebo