Clinical Trials

Date: 2014-08-25

Type of information: Treatment of the first patient

phase: 2-3

Announcement: treatment of the first patient

Company: Alexion Pharmaceuticals (USA - CT)

Product: eculizumab

Action mechanism:

• monoclonal antibody. Eculizumab is a recombinant humanized monoclonal IgG2/4 antibody that specifically binds to the complement protein C5, inhibiting its cleavage by the C5 convertase which prevents the generation of the terminal complement complex C5b-9.
• In January 2014 the FDA granted eculizumab an orphan drug designation for the prevention of  delayed graft function in renal transplant patients. Eculizumab was also granted orphan medicinal product designation from the European Commission for the prevention of delayed graft function after solid organ transplantation in February 2014.

Disease: prevention of delayed graft function after kidney transplantation

Therapeutic area: Transplantation

Country:

Trial details:

• The trial is a multinational, double-blind, placebo-controlled study with the primary objective of assessing the efficacy and safety of a two-dose regimen of eculizumab to prevent DGF in adult recipients of deceased-donor kidney transplants who are at increased risk of DGF. The primary endpoint is the incidence of DGF, defined as the requirement for dialysis for any reason in the first seven days post-treatment. Secondary endpoints include safety and tolerability as well as additional efficacy outcome measures (NCT02145182).

Latest news:

• • On August 25, 2014, Alexion Pharmaceuticals announced the initiation of dosing in a single, multinational, placebo-controlled clinical trial to evaluate the efficacy and safety of eculizumab (Soliris®) for the prevention of delayed graft function (DGF) after kidney transplantation in adult patients who are at increased risk of DGF. Patient enrollment and dosing have commenced in this trial. Recruitment is open to adults with dialysis-dependent renal failure who are to receive a first kidney transplant from a deceased donor at high-risk of developing DGF.

   

Is general: Yes