Hyperkalemia Clinical Trial
Official title:
Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia
Verified date | May 2018 |
Source | ZS Pharma, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 751 |
Est. completion date | November 30, 2016 |
Est. primary completion date | November 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
ZS Pharma, Inc. |
United States, Australia, Germany, Netherlands, Romania, South Africa, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 72 Hours | |
Primary | 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 | Study Days 85 to 365 | |
Secondary | 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 | Study Days 85 to 365 | |
Secondary | 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. | Study days 85 to 365 |
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