The Phase III Confirmatory Study is designed to confirm the safety and efficacy of KIACTATM, previously demonstrated in a Phase II/III study, in preventing kidney function decline in patients diagnosed with AA amyloidosis. AA amyloidosis is an orphan indication resulting in kidney dysfunction that often rapidly leads to dialysis and death.
The study is expected to enroll approximately 230 patients from more than 70 sites in 30 countries worldwide. To date, the study has enrolled approximately 200 patients. Enrollment is expected to be completed in the second quarter of 2014.
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