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Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study

NCT05347693 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-11-28

Study results available
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Summary

This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital. The study will compare SZC to standard of care (SoC) with the goal of determining:

* If continued use of SZC maintains normokalaemia (NK) better than SoC after participant discharge from the hospital.
* If continued use of SZC after discharge will reduce HK related healthcare resource utilisation compared to SoC.

Conditions

Interventions

DRUG

Sodium Zirconium Cyclosilicate (SZC)

White to grey crystalline powder for oral suspension in 5 g sachets. Each sachet will be labeled in accordance with Good Manufacturing Practice Annex 13 and per country regulatory requirement. Label text will be translated into local language.

DRUG

Local standard of care

Local SoC in the country to be used as per local label

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2024-12-10
Completion
2024-12-10
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT05347693 on ClinicalTrials.gov