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Phase 3 N=196 Randomized Triple-blind Treatment

A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.

Hyperkalemia

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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