Akebia completes enrollment in ongoing 200-patient Stage 2b study of AKB-6548 Akebia Therapeutics.


Butler, President and Chief Executive Officer of Akebia. ‘The completion of enrollment inside our Phase 2b research for AKB-6548 can be an essential milestone for Akebia, and we will work to develop a clinical data bundle that can position AKB-6548 as the best-in-class fresh therapy for the treatment of anemia secondary to CKD.’ The Phase 2b randomized, double-blind, placebo-controlled study is designed to evaluate the protection and efficacy of AKB-6548 for the treating anemia connected with CKD in patients who aren’t on dialysis. There are 209 patients signed up for the scholarly study at more than 50 sites over the United States. The primary reason for this research is to demonstrate an adaptive approach to dosing AKB-6548 that will enable subjects to properly raise their hemoglobin levels from baseline without excessive excursions to higher than 13.0 g/dL.All individuals were randomly designated at enrollment to 1 of the four groupings, but the results of the random assignment were concealed until patients reached the end of the induction period and their eligibility for the consolidation and maintenance regimens was verified. The scholarly study was created by the senior academic authors. The sponsor, Fondazione Neoplasie Sangue Onlus, gathered the info and, in collaboration with the senior educational authors, conducted the data analyses. Celgene supplied an unrestricted grant to carry out the trial but had not been mixed up in data collection, evaluation, or the writing of the manuscript. The initial draft of the manuscript was developed by the first author; subsequent drafts were revised by the first three authors.