Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
ZS Pharma, Inc.
It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in
maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium
levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom normokalemia was
established during the open-label acute phase versus no difference between each ZS dose
(highest to lowest) versus placebo control (null hypothesis).
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
ZS Pharma, Inc.
Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29
visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l
inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and
have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on
Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the
option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004
due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will
not be entered into study ZS-004E. All subjects who continue into the extension study must
begin dosing within two (2) days after the last dose of investigational product in ZS-004.
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be
dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month
long-term Maintenance Phase.
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