Clinical-stage biopharmaceutical company Relypsa has enrolled its first patient in a pivotal Phase III clinical study of patiromer (RLY5016), for the treatment of hyperkalemia in patients with chronic kidney disease (CKD).

Patiromer is a high capacity non-absorbed oral potassium, designed for the management of elevated serum potassium levels.

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Designed to evaluate the safety and efficacy of patiromer, the study will be conducted in two parts: Part A, the treatment phase and Part B, the withdrawal phase, under a special protocol assessment (SPA) agreement with the US Food and Drug Administration (FDA).

The single-blind, single-arm treatment phase, which will enrol 240 patients with CKD and hyperkalemia, will measure the primary endpoint as a change in serum potassium from baseline to week 4 after treatment with patiromer.

"Patiromer is a high capacity non-absorbed oral potassium, designed for the management of elevated serum potassium levels."

The company said subjects who respond to treatment in Part A will be eligible for Part B, designed to demonstrate the need for chronic treatment with patiromer.

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Qualifying subjects will be randomised either to continue on patiromer or to receive placebo for an additional eight weeks.

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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.

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 IIb 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 III study results in the fourth quarter of 2013.