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

NCT ID: NCT00615966

Last Updated: 2011-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-02-28

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.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

Diannexin

Intervention Type: DRUG

single dose, 200 µg/kg IV

2

Group Type: EXPERIMENTAL

Diannexin

Intervention Type: DRUG

Single dose, 400 µg/kg IV

3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose, IV

Interventions

Diannexin

single dose, 200 µg/kg IV

Intervention Type: DRUG

Placebo

Single dose, IV

Intervention Type: DRUG

Diannexin

Single dose, 400 µg/kg IV

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CTI Clinical Trial and Consulting Services

OTHER

Sponsor Role: collaborator

Alavita Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Alavita Pharmaceuticals Inc

Principal Investigators

Stuart Knechtle, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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

University of Wisconsin Medical School, Dept of Surgery

Madison, Wisconsin, United States

Countries

United States

References

Cheng EY, Sharma VK, Chang C, Ding R, Allison AC, Leeser DB, Suthanthiran M, Yang H. Diannexin decreases inflammatory cell infiltration into the islet graft, reduces beta-cell apoptosis, and improves early graft function. Transplantation. 2010 Oct 15;90(7):709-16. doi: 10.1097/TP.0b013e3181ed55d8.

Reference Type: DERIVED

PMID: 20634785 (View on PubMed)

Other Identifiers

DAV-CL002

Identifier Type: -

Identifier Source: org_study_id