At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Zirconium silicate (ZS) and Placebo for Hyperkalemia and 2 related conditions. Completed, enrolled 90 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
Randomized escalating doses (0.3g, 3g and 10g) of ZS (fractionated, protonated microporous Zirconium Silicate, an oral sorbent) administered 3 times daily (tid) with meals.
Randomized to mimic escalating doses of experimental drug administered 3 times daily (tid) with meals.