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

Kidney Transplantation Clinical Trial

Official title:
A Phase 2, Two-Part Study of the Safety and Tolerability of Diannexin in Kidney Transplant Recipients

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

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
View Details
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