Phase 3
N=123
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
Hyperkalemia
Bottom Line
View on ClinicalTrials.gov: NCT02107092 ↗Enrolled (actual)
123
Serious AEs
19.5%
Results posted
Aug 2018
Primary outcome: Primary: Proportion of Subjects With Average Serum Potassium Values ≤ 5.1 mmol/L — 0.875; 0.822; 0.797; 0.862 Proportion of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sodium Zirconium Cyclosilicate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ZS Pharma, Inc.
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Average Serum Potassium Values ≤ 5.1 mmol/L |
0.875; 0.822; 0.797; 0.862; 0.848; 0.793 | — |
| SECONDARY Proportion of Subjects With Average Serum Potassium Values ≤ 5.5 mmol/L |
0.950; 0.932; 0.975; 0.957; 0.955; 0.946 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent.
- Completed the ZS-004 DBRMP Study Day 29 visit or discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia and able to start dosing in ZS-004E within two (2) days after the last dose of Investigational product in ZS-004.
- Subject must have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive at the ZS-004 DBRMP Study Day 29 visit or 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 if the subject discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia .
Exclusion Criteria
- Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed blood specimen, history of severe leukocytosis or thrombocytosis.
- Subjects who received alternative treatment for hyperkalemia while participating in study ZS-004.
- Subjects with a life expectancy of less than 3 months.
- Subjects who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjects' tasks associated with the protocol.
- Women who are pregnant, lactating, or planning to become pregnant.
- Subjects with diabetic ketoacidosis.
- Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
- Known hypersensitivity or previous anaphylaxis to ZS or to components thereof.
- Treatment with a drug or device other than ZS within the last 30 days that has not received regulatory approval at the time of study entry.
- Subjects with cardiac arrhythmias that require immediate treatment.
- Subjects on dialysis.
Data sourced from ClinicalTrials.gov (NCT02107092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.