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A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8

NCT03337477 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-01-28

Study results available
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Summary

The study is designed to determine if ZS 10g administered up to three times over 10h added to insulin and glucose in patients presenting with hyperkalemia will prove tolerable and efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with insulin and glucose.

Conditions

  • Hyperkalemia

Interventions

DRUG

Placebo

Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h).

DRUG

Sodium Zirconium Cyclosilicate(ZS)

Suspension administered orally for a treatment period of 24h. Single dose contains 2 sachets of ZS 5g. 10g administered up to three times over 10h (at 0, 4 and 10h).

DRUG

Insulin

Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.

DRUG

Glucose

Glucose 25g administered IV \<15 minutes before the insulin.

DRUG

Insulin

Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.

DRUG

Glucose

Glucose 25g administered IV \<15 minutes before the insulin.

Sponsors & Collaborators

Principal Investigators

  • Frank Peacock, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-13
Primary Completion
2018-12-21
Completion
2018-12-21
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Italy
  • Russia

Study Locations

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Entities

Drugs
Companies

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 NCT03337477 on ClinicalTrials.gov