Status:
TERMINATED
Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia
Lead Sponsor:
ZS Pharma, Inc.
Conditions:
Hyperkalemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
It is hypothesized that SPS is more effective than placebo control (alternative hypothesis) in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 - 6.5 mmol/l versus...
Detailed Description
Subjects with mild to moderate hyperkalemia (i-STAT potassium levels between 5.0-6.5 mmol/l, inclusive) will be randomized 1:1 in a double-blind fashion to receive placebo or SPS (15g), administered t...
Eligibility Criteria
Inclusion
- Provision of written informed consent.
- Over 18 years of age.
- Mean i-STAT potassium values between 5.0 - 6.5 mmol/l inclusive, at screening (Study Day 0).
- Previous participation in Clinical ZS-002 or ZS-003 protocol(s). However, subjects cannot be enrolled in this study until at least 30 days have elapsed from their last dose in study ZS-003.
- 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 screening.
- Women who are surgically sterile or those who are post-menopausal for at least 2 years are not considered to be of child-bearing potential.
Exclusion
- Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed blood specimen, severe leukocytosis or thrombocytosis.
- Subjects treated with lactulose, Xifaxan or other non-absorbed antibiotics for hyperammonemia within the last 7 days.
- Subjects treated with resins (such as Sevelamer acetate), calcium acetate, calcium carbonate, or lanthanum carbonate, within the last 7 days.
- Subjects treated with Sodium Polystyrene Sulfonate (SPS; e.g. Kayexalate®) or ZS (microporous, fractionated, protonated zirconium silicate) within the last 30 days.
- Subjects with a life expectancy of less than 3 months.
- Subjects who are HIV positive.
- 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.
- Previous treatment with SPS.
- 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 insulin where a stable dose has not yet been established.\*
- Subjects on dialysis. \* Subjects on stable insulin or insulin analogues can be enrolled. Subjects who have been on the same insulin dose and regimen for \> 14 days are considered stable. Whenever possible, all blood draws collected prior to meals should be collected prior to insulin/insulin analogue treatment.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01866709
Start Date
May 1 2013
End Date
August 1 2013
Last Update
September 3 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Riverside Clinical Research
Edgewater, Florida, United States, 32132