Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperkalemia

In brief

Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis). Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more effective than placebo control (alternative hypotheses) in maintaining normokalemic levels (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between each ZS dose and respective placebo controls (null hypotheses).

Key facts

Study ID

NCT01737697

Run by

ZS Pharma, Inc.

People needed

754

Starts

2012-11-30

Expected to finish

2013-11-30

Last updated by the study team

2018-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• Saadat Ansari Internal Medicine — Huntsville, Alabama, United States
• Aspire Clinical Studies, LLC — Glendale, Arizona, United States
• Southwest Clinical Research Institute — Tempe, Arizona, United States
• California Institute of Renal Research — Chula Vista, California, United States
• Torrance Clinical Research — Lomita, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Mohammad Ismail, Inc — Paramount, California, United States
• Apex Research of Riverside — Riverside, California, United States
• Capital Nephrology Clinical Group — Sacramento, California, United States
• Pikes Peak Nephrology Associates — Colorado Springs, Colorado, United States
• Denver Nephrologists, PC — Denver, Colorado, United States
• Nephrology and Hypertension Associates — Middlebury, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• Clinical Research of Brandon — Brandon, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Endocrinology of Central Florida — Lake Mary, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• San Marcus Research Clinic — Miami, Florida, United States
• Medical Consulting Center — Miami, Florida, United States
• Elite Research Institute — Miami, Florida, United States
• Prevention & Strengthening Solutions, Inc — Miramar, Florida, United States
• PCCC of Volusia — New Smyrna Beach, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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