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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Kidney Transplantation

Clinical Trial Details

NCT number	NCT00615966
Study type	Interventional
Source	Alavita Pharmaceuticals Inc
Contact
Status	Completed
Phase	Phase 2
Start date	February 2008
Completion date	February 2010

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