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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00615966
Other study ID # DAV-CL002
Secondary ID
Status Completed
Phase Phase 2
First received February 1, 2008
Last updated June 24, 2011
Start date February 2008
Est. completion date February 2010

Study information

Verified date June 2011
Source Alavita Pharmaceuticals Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date February 2010
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 70 Years
Eligibility 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

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


Intervention

Drug:
Diannexin
single dose, 200 µg/kg IV
Placebo
Single dose, IV
Diannexin
Single dose, 400 µg/kg IV

Locations

Country Name City State
United States University of Maryland Baltimore Maryland
United States St Barnabas Medical Center Livingston New Jersey
United States University of Wisconsin Medical School, Dept of Surgery Madison Wisconsin
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

Sponsors (2)

Lead Sponsor Collaborator
Alavita Pharmaceuticals Inc CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events 28 days following administration of study medication No
Secondary Population pharmacokinetics Through Hour 48 after dosing No
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