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

This study has been completed.
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by:
Alavita Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT00615966
First received: February 1, 2008
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Kidney Transplantation
Drug: Diannexin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2, Two-Part Study of the Safety and Tolerability of Diannexin in Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Alavita Pharmaceuticals Inc:

Primary Outcome Measures:
  • Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events [ Time Frame: 28 days following administration of study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Population pharmacokinetics [ Time Frame: Through Hour 48 after dosing ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: February 2008
Study Completion Date: February 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Diannexin
single dose, 200 µg/kg IV
Experimental: 2 Drug: Diannexin
Single dose, 400 µg/kg IV
Placebo Comparator: 3 Drug: Placebo
Single dose, IV

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. 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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615966

Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, New Jersey
St Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10065
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Wisconsin
University of Wisconsin Medical School, Dept of Surgery
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Alavita Pharmaceuticals Inc
CTI Clinical Trial and Consulting Services
Investigators
Principal Investigator: Stuart Knechtle, MD Emory University
  More Information

No publications provided by Alavita Pharmaceuticals Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gordon Ringold, PhD, Alavita Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00615966     History of Changes
Other Study ID Numbers: DAV-CL002
Study First Received: February 1, 2008
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alavita Pharmaceuticals Inc:
kidney transplantation
ischemia-reperfusion injury
phosphatidylserine binding

ClinicalTrials.gov processed this record on July 29, 2014