Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
Hyperkalemia
About this trial
This is an interventional supportive care trial for Hyperkalemia
Eligibility Criteria
Inclusion Criteria:
- 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).
- Ability to have repeated blood draws or effective venous catheterization.
- Women of childbearing potential must be practicing a highly effective method of birth control.
Exclusion Criteria:
- Pseudohyperkalemia signs and symptoms, such as excessive fist clinching hemolyzed blood specimen, severe leukocytosis or thrombocytosis.
- Subjects treated with lactulose, xifaxan or other nonabsorbed antibiotics for hyperammonemia within the last 7 days.
- Subjects treated with resins (such as Sevelamer acetate or Sodium polystyrene sulfonate [SPS; e.g. Kayexalate®]), calcium acetate, calcium carbonate, or lanthanum carbonate, within the last 7 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 Ketoacidosis/Acidemia.
- 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 ZS
- 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.
- Insulin-dependent diabetes mellitus
- Subjects on dialysis
Sites / Locations
- Pinnacle Research Group
- Saadat Ansari Internal Medicine
- Aspire Clinical Studies, LLC
- Southwest Clinical Research Institute
- California Institute of Renal Research
- Torrance Clinical Research
- Academic Medical Research Institute
- Mohammad Ismail, Inc
- Apex Research of Riverside
- Capital Nephrology Clinical Group
- Pikes Peak Nephrology Associates
- Denver Nephrologists, PC
- Nephrology and Hypertension Associates
- JEM Research Institute
- Clinical Research of Brandon
- Meridien Research
- Riverside Clinical Research
- Endocrinology of Central Florida
- Meridien Research
- San Marcus Research Clinic
- Medical Consulting Center
- Elite Research Institute
- Prevention & Strengthening Solutions, Inc
- PCCC of Volusia
- Meridien Research
- Lakeview Medical Research
- Clinical Research Trials of Florida
- Metabolic Research Institute
- Research by Design
- Professional Research Network of Kansas, LLC
- Washington Nephrology Associates
- Nephrology Center DBA, Paragon Health PC
- The Center for Clinical Trials
- Clinical Research Consultants, LLC
- United Medical Associates
- Life Medi-Research and Management
- Doylestown Hospital Medical Research
- South Carolina Nephrology & Hypertension
- Carolina Diabetes and Kidney Center
- Southwest Houston Research, Ltd
- Clinical Advancement Center, PLLC
- Southern Utah Kidney and Hypertension Center
- Renal Research
- Melbourne Renal Research Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Zirconium silicate (acute phase)
Placebo (acute phase)
Zirconium silicate (subacute phase)
Placebo (subacute phase)
Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered 3 times (tid) daily with meals for 48 hours.
Placebo ( silicified microcrystalline cellulose) randomized to mimic doses of experimental drug administered 3 times (tid) daily with meals.
Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered once a day prior to the morning meal for 12 days.
Placebo (silicified microcrystalline cellulose) randomized to mimic doses of experimental drug administered once a day (qd) prior to the morning meal for 12 days.