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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02107092




Registration number
NCT02107092
Ethics application status
Date submitted
3/04/2014
Date registered
8/04/2014
Date last updated
15/08/2018

Titles & IDs
Public title
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
Scientific title
Open-label Extension to Study ZS-004 [Phase 3 Multicenter, Multi-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study of Safety Efficacy of ZS (Sodium Zirconium Cycolsilicate) in Hyperkalemia.]
Secondary ID [1] 0 0
ZS-004E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperkalemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sodium Zirconium Cyclosilicate

Experimental: Sodium Zirconium Cyclosilicate - Open label oral administration of sodium zirconium cyclosilicate 10g once daily for 11 months.


Treatment: Drugs: Sodium Zirconium Cyclosilicate
Oral 10g once daily with breakfast for 11 months.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Subjects With Average Serum Potassium Values = 5.1 mmol/L - The proportions of subjects with average serum potassium (S-K) values = 5.1 mmol/L during Extended Dosing Study Days 8 to 337, inclusive
Timepoint [1] 0 0
11 months
Secondary outcome [1] 0 0
Proportion of Subjects With Average Serum Potassium Values = 5.5 mmol/L - The proportions of subjects with average S-K values = 5.5 mmol/L during Extended Dosing Study Days 8 to 337, inclusive
Timepoint [1] 0 0
11 months

Eligibility
Key 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 .
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Supportive Care
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Gosford
Recruitment hospital [2] 0 0
- Woolloongabba
Recruitment hospital [3] 0 0
- Heidelberg
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- Woolloongabba
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
South Africa
State/province [18] 0 0
Meyerspark
Country [19] 0 0
South Africa
State/province [19] 0 0
Port Elizabeth
Country [20] 0 0
South Africa
State/province [20] 0 0
Somerset West

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ZS Pharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02107092
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henrik Rasmussen, MD, PhD
Address 0 0
ZS Pharma, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications