An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia

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NCT03813407 · readout in 1,282 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Na · None · Treatment

Enrollment

140estimated

Sites

Countries

Brazil, Canada, China +10

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2019-04-02

actual

When the study began enrolling

Primary completion

2030-02-21

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-02-21

estimated

The whole study's end, after follow-up

First posted

2019-01-23

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-13

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Hyperkalaemia

Interventions

Drug: Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level
Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1)
Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2)
Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 3 (DL3)
Drug: Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase

Primary outcomes

what the primary-completion date above is the date OF

Correction phase (CP) primary objective: To evaluate the ability to achieve normokalaemia during the CP when initiating treatment with SZC of different dose levels in children with hyperkalaemia

measured 3 days

28-day Maintenance Phase (MP) primary objective: To evaluate the ability to maintain normokalaemia during the MP when continuing SZC treatment in children achieving normokalaemia

measured last two scheduled visits in the MP

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