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NCT03337477 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
70
Enrollment target

NCT03337477: Completed Phase 2 study, sponsored by AstraZeneca.

NCT03337477 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03337477, a Phase 2 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
70 participants
Enrollment target

Study 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.

Primary Outcome

The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 4h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.

Interventions

  • DRUG Placebo
  • DRUG Insulin
  • DRUG Glucose
  • DRUG Sodium Zirconium Cyclosilicate(ZS)

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2018-02-13
Est. Completion 2018-12-21
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT03337477 record still lists

NCT03337477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT03337477 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03337477 about?

NCT03337477 is a clinical study titled "A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8". 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.

What is the current status of trial NCT03337477?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2018-02-13. Estimated completion is 2018-12-21.

What interventions are being tested in trial NCT03337477?

The interventions under investigation include: Placebo (DRUG), Insulin (DRUG), Glucose (DRUG), Sodium Zirconium Cyclosilicate(ZS) (DRUG).

Who is sponsoring clinical trial NCT03337477?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03337477's enrollment target sits among peer trials

70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03337477, the US trial registry maintained by the National Library of Medicine. NCT03337477 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.