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Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia

NCT01737697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 754

Last updated 2018-10-12

Study results available
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Summary

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).

Conditions

  • Hyperkalemia

Interventions

DRUG

Zirconium silicate (acute phase)

Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered 3 times (tid) daily with meals for 48 hours.

DRUG

Zirconium silicate (subacute phase)

Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered once a day prior to the morning meal for 12 days.

DRUG

Placebo (acute phase)

Randomized to mimic doses of experimental drug administered 3 times (tid) daily with meals for 48 hours during the acute phase.

DRUG

Placebo ( subacute phase)

Randomized to mimic doses of experimental drug administered once a day prior to the morning meal for 12 days during the subacute phase.

Sponsors & Collaborators

  • ZS Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Henrik Rasmussen, MD · ZS Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-10-31
Completion
2013-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01737697 on ClinicalTrials.gov