Auven Therapeutics and BELLUS Health Inc. have announced that the KIACTA™ Phase III Confirmatory Study in AA amyloidosis (an orphan indication) has completed its targeted enrollment of 230 patients.
Eligible patients currently in screening will also be given the opportunity to enroll in the study likely increasing total recruitment beyond 230 patients.
The Phase III Confirmatory Study is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of KIACTA™ in preventing renal function decline in patients with AA amyloidosis, which results in chronic renal failure, dialysis and death.
The objective of the study is to confirm the safety and efficacy shown in a previously conducted Phase II/III study. The study is an event-driven clinical trial that will conclude when 120 patients have experienced an event linked to deterioration of kidney function.
To date, over 60 patients have had an event. Based on the current event rate, the KIACTA™ Phase III Confirmatory Study is expected to be completed in 2016.