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

NCT00615966 | Completed Phase 2 DMC

• 1 other identifier: DAV-CL002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Kidney Transplantation

Keywords

kidney transplantation; ischemia-reperfusion injury; phosphatidylserine binding

Outcome Measures

Primary Outcomes (1)

• Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events

  28 days following administration of study medication

Secondary Outcomes (1)

• Population pharmacokinetics

  Through Hour 48 after dosing

Study Arms (3)

1

EXPERIMENTAL

Drug: Diannexin

2

EXPERIMENTAL

Drug: Diannexin

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Diannexin DRUG

single dose, 200 µg/kg IV

1

Placebo DRUG

Single dose, IV

3

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alavita Pharmaceuticals Inc: lead
• CTI Clinical Trial and Consulting Services: collaborator

Study Sites (5)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

St Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Wisconsin Medical School, Dept of Surgery

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 20634785 DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Interventions

diannexin, human

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart Knechtle, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2010
• Last Updated: June 29, 2011

Record last verified: 2011-06

Locations

US (5)