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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02163499




Registration number
NCT02163499
Ethics application status
Date submitted
11/06/2014
Date registered
13/06/2014
Date last updated
27/06/2018

Titles & IDs
Public title
Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months
Scientific title
Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia
Secondary ID [1] 0 0
ZS-005
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 -


Treatment: Drugs: Sodium Zirconium Cyclosilicate
Acute Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) for 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) based on i-STAT potassium measurements up to 12 months.

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

Outcomes
Primary outcome [1] 0 0
Percent of Participants With Restoration of Normal Serum Potassium (S-K) Values (3.5 to 5.0 mmol/L, Inclusive) at the End of the Acute Phase - Percentage of subjects with S-K values between 3.5 and 5.0 mmol/L, inclusive at the end of the Acute Phase - ITT Population
Timepoint [1] 0 0
72 Hours
Primary outcome [2] 0 0
Percentage of Participants With Mean S-K Values = 5.1 mmol/L During Extended Dosing Phase Days 85 to 365 - Percentage of subjects with mean S-K values = 5.1 mmol/L during Extended Dosing Phase - ITT Population
Timepoint [2] 0 0
Study Days 85 to 365
Secondary outcome [1] 0 0
Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12 - Proportion of Subjects with mean S-K between 3.5 and 5.5 mmol/L during Extended Dosing Phase - ITT Population
Timepoint [1] 0 0
Study Days 85 to 365
Secondary outcome [2] 0 0
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12. - Mean S-K levels months 3 to 12(EP Days 85, 113, 141, 176, 211, 239, 267, 295, 330, 365 and EOS),months 6 to 9, and months 9 to 12.
Timepoint [2] 0 0
Study days 85 to 365

Eligibility
Key inclusion criteria
- Provision of written informed consent.

- Over 18 years of age.

- Two consecutive i STAT potassium values, measured 60 (+/- 15) minutes apart, both >/=
5.1 mmol/L and measured within 1 day before the first dose of ZS on Acute Phase Study
Day 1.

- Ability to have repeated blood draws or effective venous catheterization.

- Women of childbearing potential must be using 2 forms of medically acceptable
contraception (at least 1 barrier method) and have a negative pregnancy test at Acute
Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal
for at least 2 years are not considered to be of childbearing potential.

- Controlled diabetic subjects.
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 hemolyzed blood specimen due to
excessive fist clenching to make veins prominent, difficult or traumatic venipuncture,
or history of severe leukocytosis or thrombocytosis.

- Subjects treated with lactulose, rifaximin, or other non-absorbed antibiotics for
hyperammonemia within 7 days prior to first dose of ZS on Acute Phase Study Day 1.

- Subjects treated with sodium polystyrene sulfonate (SPS; eg, Kayexalate®) or calcium
polystyrene sulfonate (eg, Resonium®) within 3 days prior to first dose of ZS on Acute
Phase Study Day 1.

- Subjects with a life expectancy of less than 12 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 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.

- Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.

- Documented GFR <15 mL/min within 90 days prior to study entry.

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
2250 - Gosford
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3073 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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Florida
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Georgia
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Michigan
Country [11] 0 0
United States of America
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Missouri
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New York
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
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Germany
State/province [18] 0 0
Berlin
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Germany
State/province [19] 0 0
Stuttgart
Country [20] 0 0
Netherlands
State/province [20] 0 0
Amsterdam
Country [21] 0 0
Romania
State/province [21] 0 0
Lasi
Country [22] 0 0
South Africa
State/province [22] 0 0
Cape Town
Country [23] 0 0
South Africa
State/province [23] 0 0
Meyerspark
Country [24] 0 0
South Africa
State/province [24] 0 0
Port Elizabeth
Country [25] 0 0
South Africa
State/province [25] 0 0
Somerset West
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Leicester

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

Ethics approval
Ethics application status

Summary
Brief summary
The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed
with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance
Phase.
Trial website
https://clinicaltrials.gov/show/NCT02163499
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