Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
Status:
Completed
Trial end date:
2015-08-31
Target enrollment:
Participant gender:
Summary
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.