Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
Public ClinicalTrials.gov record NCT01737697. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01737697
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 754 participants
Conditions and interventions
Conditions
Interventions
- Zirconium silicate (acute phase) Drug
- Zirconium silicate (subacute phase) Drug
- Placebo (acute phase) Drug
- Placebo ( subacute phase) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2012 (Actual)
- Primary completion
- Oct 31, 2013 (Actual)
- Completion
- Nov 30, 2013 (Actual)
- Last update posted
- Oct 12, 2018
2012 – 2013
United States locations
- U.S. sites
- 42
- U.S. states
- 17
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | — |
| Saadat Ansari Internal Medicine | Huntsville | Alabama | 35801 | — |
| Aspire Clinical Studies, LLC | Glendale | Arizona | 85301 | — |
| Southwest Clinical Research Institute | Tempe | Arizona | 85284 | — |
| California Institute of Renal Research | Chula Vista | California | 91910 | — |
| Torrance Clinical Research | Lomita | California | 90717 | — |
| Academic Medical Research Institute | Los Angeles | California | 90022 | — |
| Mohammad Ismail, Inc | Paramount | California | 90723 | — |
| Apex Research of Riverside | Riverside | California | 92505 | — |
| Capital Nephrology Clinical Group | Sacramento | California | 95825 | — |
| Pikes Peak Nephrology Associates | Colorado Springs | Colorado | 80909 | — |
| Denver Nephrologists, PC | Denver | Colorado | 80230 | — |
| Nephrology and Hypertension Associates | Middlebury | Connecticut | 06762 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| Clinical Research of Brandon | Brandon | Florida | 33511 | — |
| Meridien Research | Brooksville | Florida | 34601 | — |
| Riverside Clinical Research | Edgewater | Florida | 32123 | — |
| Endocrinology of Central Florida | Lake Mary | Florida | 32746 | — |
| Meridien Research | Lakeland | Florida | 33805 | — |
| San Marcus Research Clinic | Miami | Florida | 33015 | — |
| Medical Consulting Center | Miami | Florida | 33125 | — |
| Elite Research Institute | Miami | Florida | 33169 | — |
| Prevention & Strengthening Solutions, Inc | Miramar | Florida | 33023 | — |
| PCCC of Volusia | New Smyrna Beach | Florida | 32168 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Lakeview Medical Research | Summerfield | Florida | 34491 | — |
| Clinical Research Trials of Florida | Tampa | Florida | 33607 | — |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | — |
| Research by Design | Evergreen Park | Illinois | 60805 | — |
| Professional Research Network of Kansas, LLC | Wichita | Kansas | 67213 | — |
| Washington Nephrology Associates | Bethesda | Maryland | 20814 | — |
| Nephrology Center DBA, Paragon Health PC | Kalamazoo | Michigan | 49007 | — |
| The Center for Clinical Trials | Biloxi | Mississippi | 39531 | — |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | — |
| United Medical Associates | Binghamton | New York | 13903 | — |
| Life Medi-Research and Management | Brooklyn | New York | 11206 | — |
| Doylestown Hospital Medical Research | Doylestown | Pennsylvania | 18901 | — |
| South Carolina Nephrology & Hypertension | Orangeburg | South Carolina | 29118 | — |
| Carolina Diabetes and Kidney Center | Sumter | South Carolina | 29150 | — |
| Southwest Houston Research, Ltd | Houston | Texas | 77099 | — |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78215 | — |
| Southern Utah Kidney and Hypertension Center | St. George | Utah | 84770 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01737697, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 12, 2018 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01737697 live on ClinicalTrials.gov.