Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia
Public ClinicalTrials.gov record NCT01493024. 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, Prospective, Randomized, Placebo-Controlled, Double-blind Dose Escalating Study of Safety, Tolerability and Pharmacodynamics of Zirconium Silicate in Chronic Kidney Disease and Moderate Kidney Dysfunction With Mild Hyperkalemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
It is hypothesized that zirconium silicate is safe and well tolerated and more effective than placebo (alternative hypothesis) in lowering serum potassium levels in subjects with serum potassium between 5 - 6.0 mmol/l versus no difference between zirconium silicate and placebo (null hypothesis). It is hypothesized that zirconium silicate even up to the top dose of 10g three times a day is well tolerated.
Study identification
- NCT ID
- NCT01493024
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 90 participants
Conditions and interventions
Conditions
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, 2011 (Actual)
- Primary completion
- May 31, 2012 (Actual)
- Completion
- Jun 30, 2012 (Actual)
- Last update posted
- Jun 29, 2018
2011 – 2012
United States locations
- U.S. sites
- 9
- U.S. states
- 5
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Clinical Research Institute | Tempe | Arizona | 85284 | — |
| West Coast Clinical Trials | Costa Mesa | California | 92626 | — |
| Riverside Clinical Research | Edgewater | Florida | 32132 | — |
| Elite Research Institute, Inc. | Miami | Florida | 33169 | — |
| Compass Research Phase 1, LLC | Orlando | Florida | 32806 | — |
| Lakeview Medical Research | Summerfield | Florida | 34491 | — |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | — |
| Southwest Houston Research, Ltd | Houston | Texas | 77099 | — |
| Renal Associates, P.A. | San Antonio | Texas | 78215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01493024, 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 Jun 29, 2018 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01493024 live on ClinicalTrials.gov.