| Trial ID: | L0473 |
| Source ID: | NCT01493024
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| Associated Drug: |
Zirconium Silicate (Zs)
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| Title: |
Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01493024/results
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| Conditions: |
Hyperkalemia|Chronic Kidney Disease|Kidney Dysfunction
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| Interventions: |
DRUG: Zirconium silicate (ZS)|DRUG: Placebo
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| Outcome Measures: |
Primary: Difference in the Exponential Rate of Change in Serum Potassium (S-K) Levels Versus Placebo During the Initial 48 Hours of Study Drug Treatment, 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, 24 and 48 hours post first study drug dose | Secondary: Serum Potassium (S-K) at Individual Time Points., Serum potassium (S-K) at individual time points through Study day 3/0hour., First 48 hours of study|Time Specific S-K Levels to Normalization, Percent of subjects achieving S-K normalization (\<=as defined by S-K levels of 3.5 to 4.9 mmol/L) from baseline at Study Days 2 and 3 at 0 hr., 48 and 72 hours post first study drug dose|Time Specific Decreases in S-K Levels of > = 0.5 mmol/L, Percentage of participants achieving a 0.5mmol/L drop from baseline at Study Days 2 and 3 at 0 hr., 24 and 48 hours post first study drug dose|Percentage of Participants With Normal S-K Levels at End of Study Day 2, Percentage (%) of subjects who achieve S-K normalization at end of Study Day 2, 48 hours post first study drug dose|Urine Sodium Excretion, Urine sodium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2)., 24 and 48 hours post first study drug dose|Urine Potassium Excretion, Urine potassium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2)., 24 and 48 hours post study drug dose|Urea Nitrogen Excretion, Urea nitrogen excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2)., 24 and 48 hours post study drug dose|Blood Urea Nitrogen, Blood urea nitrogen compared between the combined placebo-treated controls and the ZS-treated subjects (measured 24 \& 48 hours post dose on Study Days 2 and 3)., 24 and 48 hours post study drug dose|Serum Magnesium (S-Mg) Levels, Serum magnesium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3)., 24 and 48 hours post study drug dose|Serum Calcium (S-Ca) Levels, Serum calcium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3)., 24 and 48 hours post study drug dose|Serum Sodium (S-Na) Levels, Serum sodium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3)., 24 and 48 hours post study drug dose|Serum Bicarbonate (HCO3) Levels, Serum bicarbonate compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3)., 24 and 48 hours post study drug dose|24-hour Urinary Excretion of Potassium, 24-hour urinary excretion of potassium on Study Days 1 and Day 2, 24 and 48 hours post study drug dose|24-hour Urinary Excretion of Sodium, 24-hour urinary excretion of sodium on Study Days 1 and Day 2, 48 hours|24-hour Urinary Excretion of Urea Nitrogen, 24-hour urinary excretion of urea nitrogen on Study Days 1 and Day 2, 48 hours|24-hour Urinary Excretion of Creatinine, 24-hour urinary excretion of creatinine on Study Days 1 and Day 2, 48 hours
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| Sponsor/Collaborators: |
Sponsor: ZS Pharma, Inc.
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
90
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
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| Start Date: |
2011-11-30
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| Completion Date: |
2012-06-30
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| Results First Posted: |
2018-06-29
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| Last Update Posted: |
2018-06-29
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| Locations: |
Southwest Clinical Research Institute, Tempe, Arizona, 85284, United States|West Coast Clinical Trials, Costa Mesa, California, 92626, United States|Riverside Clinical Research, Edgewater, Florida, 32132, United States|Elite Research Institute, Inc., Miami, Florida, 33169, United States|Compass Research Phase 1, LLC, Orlando, Florida, 32806, United States|Lakeview Medical Research, Summerfield, Florida, 34491, United States|Johnson County Clin-Trials, Lenexa, Kansas, 66219, United States|Southwest Houston Research, Ltd, Houston, Texas, 77099, United States|Renal Associates, P.A., San Antonio, Texas, 78215, United States
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| URL: |
https://clinicaltrials.gov/show/NCT01493024
|
