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

Completed · Phase 2 · Has a placebo group

Conditions studied: Kidney Transplantation

In brief

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

Key facts

Study ID

NCT00615966

Run by

Alavita Pharmaceuticals Inc

People needed

58

Starts

2008-02-01

Expected to finish

2010-02-01

Last updated by the study team

2011-06-29

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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