NCT00615966

A Phase 2, Two-Part Study of the Safety and Tolerability of Diannexin in Kidney Transplant Recipients

Completed Phase 2 Last updated 24 June 2011

What this trial tests

Phase 2 trial testing Diannexin in Kidney Transplantation in 58 participants. Completed in 1 February 2010.

Timeline

1 February 2008

Primary endpoint
1 January 2009

1 February 2010

Quick facts

Lead sponsor	Alavita Pharmaceuticals Inc
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	58
Start date	1 February 2008
Primary completion	1 January 2009
Estimated completion	1 February 2010
Sites	5 locations across United States

Drugs / interventions tested

• Diannexin — full drug profile →
• Placebo
• Diannexin — full drug profile →

Conditions studied

• Kidney Transplantation — all drugs for Kidney Transplantation →

Sponsor

Alavita Pharmaceuticals Inc — full company profile →

Who can join

Adults 21 to 70, any sex, with Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events
  Time frame: 28 days following administration of study medication

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cellular and molecular mechanisms of cell damage and cell death in ischemia-reperfusion injury in organ transplantation.
   Dugbartey GJ. · · 2024 · cited 38× · PMID 38553658 · DOI 10.1007/s11033-024-09261-7
2. Therapeutic Potential of Annexins in Sepsis and COVID-19.
   Mui L, Martin CM, Tschirhart BJ, Feng Q. · · 2021 · cited 26× · PMID 34566657 · DOI 10.3389/fphar.2021.735472
3. Diannexin decreases inflammatory cell infiltration into the islet graft, reduces β-cell apoptosis, and improves early graft function.
   Cheng EY, Sharma VK, Chang C, Ding R, et al · · 2010 · cited 21× · PMID 20634785 · DOI 10.1097/tp.0b013e3181ed55d8
4. Protective Effect of Phosphatidylserine Blockade in Hemorrhagic Shock.
   Cohan C, Beattie G, Brigode W, Yeung L, et al · · 2020 · cited 4× · PMID 31499368 · DOI 10.1016/j.jss.2019.07.050