Status:
COMPLETED
Phase 2 Study of the Safety of Diannexin in Kidney Transplant Recipients
Lead Sponsor:
Alavita Pharmaceuticals Inc
Collaborating Sponsors:
CTI Clinical Trial and Consulting Services
Conditions:
Kidney Transplantation
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00615966
Start Date
February 1 2008
End Date
February 1 2010
Last Update
June 29 2011
Active Locations (5)
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1
University of Maryland
Baltimore, Maryland, United States, 21201
2
St Barnabas Medical Center
Livingston, New Jersey, United States, 07039
3
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10065
4
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157