Phase 3
Completed N=196
A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
Source: ClinicalTrials.gov NCT03303521 ↗Enrolled (actual)
196
Serious AEs
7.7%
Results posted
Feb 2020
Primary outcomePrimary: Percentage of Responders — 41.2; 1.0 Percentage of participants — p=<0.001
◆ Published Evidence
Established
46citations · ~8 / year
Potassium binders for chronic hyperkalaemia in people with chronic kidney disease.
Summary
The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
Linked Publications (2)
-
Potassium binders for chronic hyperkalaemia in people with chronic kidney disease.
-
Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders |
41.2; 1.0 | <0.001 sig |
| PRIMARY Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data |
42.3; 2.0 | <0.001 sig |
| SECONDARY Percentage of Patients Needing Rescue Therapy |
2.1; 5.1 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Female or male aged ≥ 18 years at screening Visit 1. For patients aged 5.4 mmol/L after long inter-dialytic interval and >5.0 mmol/L after one short inter-dialytic interval during screening (as assessed by central lab).
- Prescribed dialysate K concentration ≤ 3 mmol/L during screening
- Sustained Qb ≥200 ml/min and spKt/V ≥1.2 (or URR ≥ 63) on stable hemodialysis/hemodiafltration prescription during screening with prescription (time, dialyzer, blood flow [Qb], dialysate flow rate [Qd] and bicarbonate concentration) expected to remain unchanged during study
- Heparin dose (if used) must be stable during screening and expected to be stable during the study
- Subjects must be receiving dietary counseling appropriate for ESRD patients treated with hemodialysis/hemodiafiltration as per local guidelines, which includes dietary potassium restriction.
Exclusion Criteria
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca, including ZS Pharma staff and/or staff at the study site)
- Hemoglobin 20× 10^9/L) or thrombocytosis (≥450 × 10^9/L) during screening
- Polycythemia (Hb >14 g/dL) during screening
- Diagnosis of rhabdomyolysis during the 4 weeks preceding randomization
- Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug
- Patients unable to take oral ZS drug mix
- Scheduled date for living donor kidney transplant
- Patients with a life expectancy of less than 6 months
- Female patients who are pregnant or breastfeeding
- Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
- Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
- Participation in another clinical study with an investigational product during the last 1 month before screening
- Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation
- Presence of cardiac arrhythmias or conduction defects that require immediate treatment
- History of alcohol or drug abuse within 2 years prior to randomization
- Previous randomization in the present study
Data sourced from ClinicalTrials.gov (NCT03303521) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.