The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney transplant recipients.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
58
University of Maryland
Baltimore, Maryland, United States
St Barnabas Medical Center
Livingston, New Jersey, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events
Time frame: 28 days following administration of study medication
Population pharmacokinetics
Time frame: Through Hour 48 after dosing
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University of Wisconsin Medical School, Dept of Surgery
Madison, Wisconsin, United States