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

Phase 2

Completed

Brief Summary: The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney transplant recipients.

Detailed Description: Ischemia-reperfusion injury, which occurs when the blood supply to an organ, or part of an organ, is cut off and subsequently restored, is an important clinical problem in the organ transplant setting. Diannexin, a recombinant form of the endogenous human Annexin V protein, is in development as a therapeutic agent designed to prevent ischemia-reperfusion injury following organ transplantation. Pharmacology studies indicate that Diannexin has protective effect in various ischemia-reperfusion injury and organ transplantation models. Diannexin binds to phosphatidylserine on cell surfaces, which is believed to underlie its ability to attenuate ischemia-reperfusion injury. In a completed Phase 1 trial, Diannexin was judged safe and well tolerated in healthy adult subjects. The present study is designed to determine the safety and tolerability of single escalating doses of Diannexin in kidney transplant recipients.

Recruitment & Eligibility

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

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events	28 days following administration of study medication

Secondary Outcome Measures

Name	Time	Method
Population pharmacokinetics	Through Hour 48 after dosing

Locations (5): University of Maryland
🇺🇸
Baltimore, Maryland, United States
St Barnabas Medical Center
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Livingston, New Jersey, United States
University of Wisconsin Medical School, Dept of Surgery
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Madison, Wisconsin, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
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New York, New York, United States
Wake Forest University Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States