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NCT01493024 · ClinicalTrials.gov registry record · Phase 2
Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia
A Phase 2 study of Chronic Kidney Disease and Hyperkalemia, sponsored by ZS Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 9
- Study locations
NCT01493024: Completed Phase 2 study of Chronic Kidney Disease and Hyperkalemia, sponsored by ZS Pharma.
NCT01493024 is a Phase 2 study of Chronic Kidney Disease and Hyperkalemia that has completed, run by ZS Pharma. The registered enrollment target is 90 participants, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (97% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01493024, a Phase 2 study of Chronic Kidney Disease and Hyperkalemia, has completed, sponsored by ZS Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 9
- Study locations
Study Summary
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.
Primary Outcome
The rate of fall in S-K levels during the initial 48 hours of study drug treatment between the placebo treated subjects and the ZS treated subjects measured on a log scale
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Zirconium silicate (ZS)
Study Locations (9)
Florida
- Riverside Clinical Research - Edgewater
- Elite Research Institute, Inc. - Miami
- Compass Research Phase 1, LLC - Orlando
- Lakeview Medical Research - Summerfield
Texas
- Southwest Houston Research, Ltd - Houston
- Renal Associates, P.A. - San Antonio
Arizona
- Southwest Clinical Research Institute - Tempe
California
- West Coast Clinical Trials - Costa Mesa
Kansas
- Johnson County Clin-Trials - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2011-11-30 |
| Est. Completion | 2012-06-30 |
| Phase | Phase 2 |
What the finished NCT01493024 record still lists
NCT01493024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01493024 lists 9 locations in 5 states (Florida, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT01493024 about?
NCT01493024 is a clinical study titled "Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia". 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 ...
What is the current status of trial NCT01493024?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2011-11-30. Estimated completion is 2012-06-30.
What conditions does trial NCT01493024 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Hyperkalemia, Kidney Dysfunction.
What interventions are being tested in trial NCT01493024?
The interventions under investigation include: Placebo (DRUG), Zirconium silicate (ZS) (DRUG).
Who is sponsoring clinical trial NCT01493024?
This trial is sponsored by ZS Pharma, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01493024 being conducted?
This trial has 9 study locations across Arizona, California, Florida, Kansas, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01493024's enrollment target sits among peer trials
90 61st of 101 higher than 40 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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