Terminated PHASE3 INTERVENTIONAL 2-arm NCT04727528

Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease (NEUTRALIZE)

A Double-blind Randomized Placebo-controlled Parallel Design Multicenter Phase IIIb Study of the Effect of Sodium Zirconium Cyclosilicate (SZC) on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease (NEUTRALIZE)

Sponsor: AstraZeneca

Conditions Chronic Kidney Disease Hyperkalaemia Metabolic Acidosis

Interventions Placebo Sodium zirconium cyclosilicate

Updated 17 times since 2021 Last updated: Oct 5, 2023 Started: Mar 22, 2021 Primary completion: Sep 14, 2022 Completion: Sep 14, 2022

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was stopped due to a higher than expected screen fail rate (83%) which lead to very low patient enrollment into the study. It should be noted that the decision to terminate the study is not related to safety concerns.

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Listed as NCT04727528, this PHASE3 trial focuses on Chronic Kidney Disease and Hyperkalaemia and remains terminated or withdrawn. Sponsored by AstraZeneca, it has been updated 17 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

17 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Nov 2023 — Jul 2024 [monthly]

Terminated PHASE3
Jan 2023 — Nov 2023 [monthly]

Terminated PHASE3

Status: Recruiting → Terminated

▶ Show 12 earlier versions

Sep 2022 — Jan 2023 [monthly]

Recruiting PHASE3
Jul 2022 — Sep 2022 [monthly]

Recruiting PHASE3
May 2022 — Jul 2022 [monthly]

Recruiting PHASE3
Apr 2022 — May 2022 [monthly]

Recruiting PHASE3
Feb 2022 — Apr 2022 [monthly]

Recruiting PHASE3
Jan 2022 — Feb 2022 [monthly]

Recruiting PHASE3
Dec 2021 — Jan 2022 [monthly]

Recruiting PHASE3
Nov 2021 — Dec 2021 [monthly]

Recruiting PHASE3
Sep 2021 — Nov 2021 [monthly]

Recruiting PHASE3
Jun 2021 — Sep 2021 [monthly]

Recruiting PHASE3
May 2021 — Jun 2021 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Feb 2021 — May 2021 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

AstraZeneca

Data source: AstraZeneca

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Alexandria, United States , Asheville, United States , Aurora, United States , Bellevue, United States , Chattanooga, United States , Chula Vista, United States , Columbus, United States , Coral Gables, United States , Dallas, United States , Denver, United States and 19 more locations