A study to investigate the long term safety and effectiveness of ZS (the study drug which is taken orally and acts by absorbing potassium) in patients with Hyperkalemia (excess potassium).

Phase 1

• Conditions: Hyperkalemia; MedDRA version: 19.0Level: LLTClassification code 10020647Term: HyperkalemiaSystem Organ Class: 100000004861; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2014-004555-31-DE
• Lead Sponsor: ZS Pharma Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-31
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

1.Provision of written informed consent.
2.Age 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 385
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 365

Exclusion Criteria

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 entry.
15. For Germany only: Subjects presenting with QTc Interval of 450 ms
AND additional 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified