A Phase 3 Multicenter, Multi-dose, Open-label Maintenance Study to Investigate the Long-term Safety and Efficacy of ZS (Sodium Zirconium Cyclosilicate), an Oral Sorbent, in Subjects with Hyperkalemia
- Conditions
- high potassium levels in bloodhyperkalemia10014412
- Registration Number
- NL-OMON43860
- Lead Sponsor
- ZS Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1). Provision of written informed consent.
2).18 years and older.
3). For all subjects enrolled outside Germany: 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.
For all subjects enrolled in Germany: Two consecutive i -STAT potassium values, measured 60 (+/-15) minutes apart, both * 5.1 mmol/L and * 6.5 mmol/l and measured within 1 day before the first dose of ZS on Acute Phase Study Day 1.
4). Ability to have repeated blood draws or effective venous catheterization.
5). For all subjects outside the European Union: Women of childbearing potential must have a negative pregnancy test within 1 day prior to the first dose of ZS on Acute Phase Study Day 1 and sexually active women of childbearing potential must be using 2 forms of medically acceptable contraception with at least one being a barrier method. Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential.
For all subjects in the European Union: Women of childbearing potential must have a negative pregnancy test within 1 day prior to the first dose of ZS on Acute Phase Study Day 1 and sexually active women of childbearing potential must be using a highly effective medically acceptable contraception such as:
* combined or hormonal contraception associated with inhibition of ovulation;
* progesterone only hormonal contraception, associated with inhibition of ovulation;
* IUD (intrauterine device);
* IUS (intrauterine hormone-releasing system);
* bilateral tubal occlusion;
* vasectomised partner;
* sexual abstinence (true abstinence in line with the subjects preferred and usual lifestyle). Subjects practicing abstinence will agree to have a documented second acceptable method of birth control should they become sexually active during the course of study participation).
Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential.
Note: Controlled diabetic subjects are eligible for enrollment. Whenever possible, all blood draws collected before meals should be collected prior to insulin/insulin analog treatment.
1). 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.
2). 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.
3). 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.
4). Subjects with a life expectancy of less than 12 months.
5). 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.
6). Women who are pregnant, lactating, or planning to become pregnant.
7). Subjects with diabetic ketoacidosis.
8). 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.
9). Known hypersensitivity or previous anaphylaxis to ZS or to components thereof.
10). Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
11). Subjects with cardiac arrhythmias that require immediate treatment.
12). Subjects on dialysis.
13). Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.
14). Documented GFR < 15 mL/min within 90 days prior to study.
15). For Germany only: subjects presenting wiht QTc interval of 450 ms AND addtional risk factors for Torsade de pointes (e.g. heart failure or family history of long QT-syndrome) AND taking concomitant medications causing QT prolongation.
16). For Germany only: Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
17). For Germany only: subjects who are dependents of either the Sponsor, Investigator or Institution
Note: Subjects who do not meet the criteria for entering the Acute Phase may be re-screened 2 more times during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints will be safety and tolerability as measured by adverse<br /><br>event reporting, vital signs, ECGs, physical examinations and safety laboratory<br /><br>measurements.</p><br>
- Secondary Outcome Measures
Name Time Method