Clinical-stage biopharmaceutical company Relypsa has finished enrolling patients with chronic kidney disease (CKD) in a pivotal Phase III programme of patiromer for the treatment of hyperkalemia.
Patiromer (RLY5016) for oral suspension is a high-capacity non-absorbed oral potassium binder that the company is developing for the management of elevated serum potassium levels.
The Phase III trial is a two-part study being conducted under an agreed special protocol assessment (SPA) with the US FDA.
Relypsa president Dr Gerrit Klaerner said the rapid enrolment marks patiromer’s potential in fulfilling a significant medical need and that nephrologists are embracing the concept of a novel, chronic treatment of hyperkalemia.
"Completing enrolment of our pivotal programme is a significant milestone that allows Relypsa to ramp up preparations to seek NDA approval and for commercial launch," Klaerner said.
Part A of the study will be conducted in 240 patients with CKD and hyperkalemia.
Change in serum potassium from baseline to week four after treatment with patiromer is the primary endpoint of the patiromer treatment phase of the single-blind, single-arm trial.
Subjects responding to treatment in Part A will enter into the withdrawal phase of the study, Part B, which is designed to establish the need for chronic treatment with patiromer.
The study will randomise the subjects either to continue on patiromer or to receive placebo for eight more weeks.
The Part B analysis will establish the difference in the change in serum potassium from baseline to week four.
Top-line results from the study are expected in the latter half of 2013.