Phase 3
N=196
A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
Hyperkalemia
Bottom Line
View on ClinicalTrials.gov: NCT03303521 ↗Enrolled (actual)
196
Serious AEs
7.7%
Results posted
Feb 2020
Primary outcome: Primary: Percentage of Responders — 41.2; 1.0 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Sodium Zirconium Cyclosilicate (ZS) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2018
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 | — |
Summary
The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
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). 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.