Study of Sodium Zirconium Cyclosilicate to Control Interdialytic Hyperkalemia Following Augmentation of Dialysate Potassium: Efficacy to Reduce the Incidence of Post-Dialysis Atrial Fibrillation and Clinically Significant Cardiac Arrhythmias

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    End Stage Renal Disease (esrd)
  • Age: Between 18 years - 90 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Patients with end-stage renal disease (ESRD) receiving hemodialysis three times per week for a minimum of 3 months.
    2. Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control.

You may not be eligible for this study if the following are true:

    1. Patients with Congenital long QT syndrome.
    2. Patients with active, significant infection or liver disease.
    3. Patients receiving peritoneal or home hemodialysis.
    4. Patients receiving outpatient hemodialysis via a tunneled inferior vena cava (IVC) catheter and known central stenosis of access extremity.
    5. Patients receiving outpatient hemodialysis for less than 3 months.
    6. Patients receiving outpatient hemodialysis for prolonged Acute Kidney Injury (AKI) and likely to achieve renal recovery within 6 months.
    7. Patients unwilling to convert to a 2.0 K+/2.5 Ca++ dialysate bath or a 3.0 K+ dialysate bath.
    9. Current use of a medication for treatment of hyperkalemia.
    11. Chronic atrial fibrillation.
    13. Patients with a known placement of a dual or single chamber pacemaker.
    15. Patients with an automatic implantable cardiac defibrillator (AICD).
    17. Current use of amiodarone or other anti-arrhythmic therapy.
    19. Known history of cardiac arrhythmias due to prolonged QT syndrome.
    21. Participant unwilling to receive and implanted LINQ cardiac loop recorder.
    23. History of active drug abuse.
    25. Positive hepatitis C or chronic active hepatitis B.
    27. Positive for human immunodeficiency virus (HIV).
    29. For women only: currently pregnant or breastfeeding.
    31. Patients with known and/or active severe constipation, bowel obstruction or impaction.
    33. Known hypersensitivity to sodium zirconium cyclosilicate (Lokelma).
    35. Participation in another drug or device study within 4 weeks.



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