Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
Status:
Completed
Trial end date:
2013-11-30
Target enrollment:
Participant gender:
Summary
Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo
control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 -
6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis).
Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more
effective than placebo control (alternative hypotheses) in maintaining normokalemic levels
(3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between
each ZS dose and respective placebo controls (null hypotheses).