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 Details — Status: Completed

Administrative data

• NCT number: NCT00615966
• Other study ID #: DAV-CL002
• 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

• Kidney Transplantation

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