Clinical trial NCT01279538 (phase 1, status: completed)
Conditions: kidney transplantation
ICD codes: N26.2, Q63.0, Q63.2, Z52.4, I75.81, N19, N20.0
Drugs: bleselumab, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a recipient of a de novo kidney transplant from a living or deceased donor

          -  Prior to randomization, the subject has a post-transplant serum creatinine value that
             is at least 30% decreased from the pre-transplant value and requires no dialysis

          -  Female subject of child bearing potential must have a negative serum pregnancy test
             within 7 days prior to enrollment or upon hospitalization and must agree to maintain
             effective birth control during the study

          -  All sexually active male subjects must agree to use an adequate method of
             contraception throughout the study period and for 90 days after the last dose of study
             drug and agrees to no sperm donation until the end of the study, or for 90 days after
             the last dose of study drug, whichever is longer

          -  Subject must be willing and able to comply with the study requirements including
             prohibited concomitant medication restrictions

        Exclusion Criteria:

          -  Prior to randomization, subject will receive antibody induction therapy (e.g.,
             thymoglobulin, basiliximab, daclizumab, OKT3, alemtuzumab)

          -  Subject has previously received or is receiving an organ transplant other than a
             kidney

          -  Recipient has a positive T or B cell crossmatch

          -  Subject has ABO blood type incompatibility with their donor

          -  Subject has received intravenous immunoglobulin (IVIG) therapy in the 3 months prior
             to first dose of study drug

          -  Recipient or donor is known by medical history to be seropositive for human
             immunodeficiency virus (HIV)

          -  Subject had a thromboembolic event (e.g., myocardial infarction, cerebrovascular
             event, pulmonary embolus, deep vein thrombosis, peripheral arterial thromboembolic
             event) in the past 5 years or if the subject is on specific therapy for prophylaxis or
             treatment of such an event. Low dose aspirin (81 mg) therapy is not considered
             exclusionary. NOTE: A one-time event of arterio-venous (AV) fistula dialysis access
             thrombosis is not exclusionary. Subjects with recurrent AV fistula thrombosis or those
             on systemic medications to prevent reoccurrence are excluded

          -  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 has an uncontrolled concomitant infection or any other unstable medical
             condition that could interfere with the study objectives

          -  Subject is concurrently participating in another drug study or has received an
             investigational drug up to 8 weeks (depending on medication) prior to transplant

          -  Subject has previously received ASKP1240 or participated in a study involving ASKP1240

          -  Subject has abnormal chest x-ray indicative of acute or chronic lung disease on a
             prior examination within 3 months prior to randomization

          -  Subject has abnormal electrocardiogram (ECG) considered as clinically significant on a
             prior examination within 3 months prior to randomization

          -  Subject has uncontrolled intercurrent illness, including, but not limited to ongoing
             or active infection, any clinically significant cardiac disease, seizure disorder, or
             psychiatric illness/social situations that would limit compliance with study
             requirements

          -  Subject has received live or live attenuated virus vaccinations within the last 30
             days prior to first dose of study drug

          -  Subject has a clinical condition which would not allow safe conduct and completion of
             the study

          -  Subject is pregnant or lactating