Patiromer is a high capacity non-absorbed oral potassium used for the management of elevated serum potassium levels, according to the company.
Conducted in two parts, the study’s Part A, the treatment phase, is a single-blind, single-arm pivotal study which will enroll 240 patients with CKD and hyperkalemia, and subjects who respond to treatment in Part A will be eligible for Part B, the withdrawal phase.
The primary endpoint for Part A is a change in serum potassium from baseline to week 4 after treatment with patiromer, while the primary analysis is the between group difference in the change in serum potassium from baseline to week 4 of Part B, according to the company.
Qualifying subjects will be randomized either to continue on patiromer or to receive placebo for an additional eight weeks.
University of Maryland School of Medicine nephrology division director and trial principal investigator professor Matthew Weir said, "Having observed the efficacy and safety data from the phase 2b study presented at ASN in 2012, I am confident this pivotal study will demonstrate the efficacy and safety of patiromer for the treatment of hyperkalemia in CKD patients receiving renin angiotensin and/or aldosterone blockade."
The company is expecting to report phase 3 study results in the fourth quarter of 2013.