Phase 2 Study of the Safety of Diannexin in Kidney Transplant Recipients

Inclusion Criteria:

• Scheduled to receive a kidney transplant from a deceased expanded criterion donor (ECD) or a donor cardiac death (DCD) donor that was exposed to no more than 36 hr of cold ischemia prior to transplantation, or scheduled to receive a kidney transplant from a standard criterion donor (SCD) that was exposed to 24-36 hr of cold ischemia prior to transplantation
• Willing to use adequate contraception for at least 4 weeks after dosing
• Willing and able to provide written Informed Consent and to comply with the requirements of the study

Exclusion Criteria:

• If female, subject is pregnant or lactating
• Known bleeding diathesis
• INR at Screening > 1.5
• Platelet count at Screening below LLN and judged clinically significant
• Use of Plavix, anticoagulants other than aspirin, antithrombotics, and/or blood-thinning agents within 10 days prior to study entry
• Previous receipt of an organ transplant
• Will receive concurrent transplant of any additional organ(s)
• Clinically significant active infection at study entry
• Surgery within 2 weeks prior to study entry
• Believed to have used an illicit drug and/or abused alcohol within 3 months prior to study entry
• Presence of a psychiatric illness that might interfere with study participation
• Cancer, other than basal cell or squamous cell cancer of the skin, within 2 years prior to study entry
• Scheduled to receive a kidney transplant from a low risk donor
• Currently participation, or participated within 30 days prior to study entry, in an investigational drug study
• Known allergy to kanamycin
• History or presence of any medical condition or disease that could place the subject an unacceptable risk for study participation