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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02088073




Registration number
NCT02088073
Ethics application status
Date submitted
12/03/2014
Date registered
14/03/2014
Date last updated
7/12/2018

Titles & IDs
Public title
Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
Scientific title
Multicenter, Multi-phase, Multi-dose, Prospective, Double-blind, Placebo-controlled, Maintenance Study of Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate) in Hyperkalemia.
Secondary ID [1] 0 0
ZS-004
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
Treatment: Drugs - Placebo

Experimental: Sodium zirconium cyclosilicate 10 g three times daily - Sodium zirconium cyclosilicate 10 g three times daily for 48 hours (acute phase)

Placebo comparator: Placebo once daily - Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days.

Experimental: Sodium zirconium cyclosilicate 5 g once daily - Sodium zirconium cyclosilicate (ZS) 5 g once daily for 28 days (maintenance phase)

Experimental: Sodium zirconium cyclosilicate 10 g once daily - Sodium zirconium cyclosilicate (ZS) 10 g once daily for 28 days (maintenance phase)

Experimental: Sodium zirconium cyclosilicate 15 g once daily - Sodium zirconium cyclosilicate (ZS) 15 g once daily for 28 days (maintenance phase)


Treatment: Drugs: Sodium zirconium cyclosilicate
Sodium zirconium cyclosilicate

Treatment: Drugs: Placebo
Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days (maintenance phase)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population).
Timepoint [1] 0 0
22 Days; Maintenance Phase Days 8 - 29, inclusive.
Secondary outcome [1] 0 0
The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT).
Timepoint [1] 0 0
22 days; Maintenance Phase Day 8 - 29, inclusive.
Secondary outcome [2] 0 0
Mean Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit .
Timepoint [2] 0 0
Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive.
Secondary outcome [3] 0 0
Mean Percent Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit, Inclusive .
Timepoint [3] 0 0
Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive.
Secondary outcome [4] 0 0
Mean Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit.
Timepoint [4] 0 0
Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive.
Secondary outcome [5] 0 0
Mean Percent Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit.
Timepoint [5] 0 0
Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive.
Secondary outcome [6] 0 0
Median Time to Hyperkalemia (S-K = 5.1mmol/L)
Timepoint [6] 0 0
Maintenance Phase baseline to maintenance Phase Study Day 29/Exit.
Secondary outcome [7] 0 0
Mean S-K Intra-subject Standard Deviation Calculated Among Subjects With = 2 Values on or After Maintenance Phase Study Day 8
Timepoint [7] 0 0
22 days; Maintenance Phase Day 8 - 29
Secondary outcome [8] 0 0
Proportion of Subjects Who Remained Normokalemic During Maintenance Phase
Timepoint [8] 0 0
Maintenance Phase Study Days 1, 2, 5, 8, 12, 15, 19, 22, 26, 29, and 35, inclusive.
Secondary outcome [9] 0 0
Median Time to Relapse in S-K Values
Timepoint [9] 0 0
Maintenance phase Study Day 1 to Study Day 29/Exit.
Secondary outcome [10] 0 0
Exponential Rate of Change in S-K Values During the Acute Phase at 24 Hours and 48 Hours of Study Drug Treatment.
Timepoint [10] 0 0
Acute Phase 24 hours and Acute Phase 48 hours.
Secondary outcome [11] 0 0
Mean Change From Baseline in S-K Values (Blood) at All Measured Time Intervals Post Dose Acute Phase.
Timepoint [11] 0 0
All measured time intervals post dose during the Acute Phase.
Secondary outcome [12] 0 0
Mean Percent Change From Baseline in S-K Values (Blood) at All Measured Time Intervals Post Dose Acute Phase.
Timepoint [12] 0 0
All measured time intervals post dose during the Acute Phase.
Secondary outcome [13] 0 0
Proportion of Subjects Who Achieve Normokalemia During the Acute Phase at 24 and 48 Hours After Start of Dosing
Timepoint [13] 0 0
Through 48 hours acute phase
Secondary outcome [14] 0 0
Median Time to Normalization (3.50-5.0 mmol/L) in S-K Levels in the 48 Hours of Initial Treatment
Timepoint [14] 0 0
Through 48 hours acute phase

Eligibility
Key inclusion criteria
* Provision of written informed consent.
* Over 18 years of age.
* Two consecutive i-STAT potassium values, measured 60-minutes apart, both =5.1 mmol/l and measured within 1 day of the first ZS dose on AP Study Day 1.
* Ability to have repeated blood draws or effective venous catheterization.
* Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method) and have a negative pregnancy test at AP Study Day 1. Women who are surgically sterile or those who are post-menopausal for at least 2 years are not considered to be of childbearing potential.
Minimum age
18 Years
Maximum age
No limit
Sex
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 treated with lactulose, Xifaxan or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug.
* Subjects treated with resins (such as sevelamer acetate or sodium polystyrene sulfonate [SPS; e.g. Kayexalate®]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug.
* 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.
* Randomization into the previous ZS-002 or ZS-003 studies.
* 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
31/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2015
Sample size
Target
Accrual to date
Final
258
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02088073