TerminatedPhase 3

A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia

Stopped: The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely.

United States1,112 participantsStarted 2021-09-30

Plain-language summary

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate \[eGFR\] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. Cohort A: Hyperkalaemia (S-K \> 5.0 to ≤ 6.5 mmol/L) as measured by the central laboratory, and on adequate\* or limited\*\* RAASi therapy due to hyperkalaemia.
✓. Cohort B: Normokalaemia (S-K ≥ 3.5 to ≤ 5.0 mmol/L) as measured by the central laboratory and on limited\*\* RAASi therapy due to high risk of hyperkalaemia. High risk of hyperkalaemia is defined as:

What they're measuring

Total eGFR Slope (Coprimary Analysis #1)

Timeframe: Baseline (Maintenance phase) to visit 17 (week 69)

Chronic eGFR Slope (Coprimary Analysis #2)

Timeframe: 12 weeks to visit 17 (week 69)

Trial details

NCT IDNCT05056727

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-07

Results submitted2025-02-12

View on ClinicalTrials.gov More Renal Insufficiency, Chronic trials