Trial of Post-Op Drug for Dialysis Patients to Proceed
Special Protocol Assessment (SPA) approval has been given to Ark Therapeutics Group plc of
Results of a phase II open-label, non-randomized trial showed that access grafts of patients who received the planned dose of Trinam exhibited almost three times the primary unassisted patency compared with controls.
The phase III study will be a
The resulting data were in line with previous findings, allowing the phase III trial to include this procedure alongside the existing “end-to-end” placement procedure used in phase II.
In addition to beginning work on the phase III trial, the company intends to apply to the FDA for fast-track designation.