Relypsa, Inc. Announces Agreement With FDA on Special Protocol Assessment for Patiromer Phase 3 Trial for the Treatment of Hyperkalemia
1/3/2013 9:30:28 AM
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Relypsa, Inc., a clinical-stage biopharmaceutical company, announced today a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of the Company’s pivotal, Phase 3 trial evaluating the efficacy and safety of patiromer for the treatment of hyperkalemia (high serum potassium levels) in patients with chronic kidney disease (CKD). The Phase 3 trial will consist of two parts, each serving as a pivotal study for the purposes of the New Drug Application (NDA) submission: Part A of the trial, the patiromer treatment phase, is a single-blind, single-arm study designed to enroll approximately 240 patients with CKD and hyperkalemia. The primary endpoint of Part A is change in serum potassium from baseline to week 4 after treatment with patiromer.