Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05535920
Eligibility Criteria:
Inclusion Criteria:
* Provision of informed consent prior to any study-specific procedures
* Female or male aged above 18 years
* Patients with ESRD receiving hemodialysis three times per week for a minimum of 3 months
* Patients must have two (2) pre-dialysis K+ measurements between 5.1 and 6.5 mEq/L by Piccolo POCT following the long dialytic "weekends" (i.e., on two consecutive Mondays for patients on a Monday-Wednesday-Friday dialysis schedule or on two consecutive Tuesdays for patients on a Tuesday-Thursday-Saturday dialysis schedule) during screening, before insertion of the cardiac loop recorder.
* Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) They should have been stable on their chosen method of birth control for a minimum of 1 month before entering the study and willing to remain on the birth control until 4 weeks after the last dose.
Exclusion Criteria:
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Exclusion Criteria Related to the Underlying Condition:
* Patients with a QTc(f) \> 550 msec and/or Congenital long QT syndrome
* Patients with a Haemoglobin \< 9 g/dl.
* Patients with any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or Sponsor may pose a safety risk to a subject in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation.
* Patient receiving peritoneal or home hemodialysis
* Patient receiving hemodialysis via a tunneled inferior vena cava (IVC) catheter and known central stenosis of access extremity
* Patient receiving outpatient hemodialysis for \< 3 months
* Patient receiving outpatient hemodialysis for prolonged Acute Kidney Injury (AKI) and considered by the site Principal Investigator (PI) likely to achieve renal recovery within 6 months Note: Patients receiving out-patient hemodialysis for AKI for longer than 6 months with no demonstrable renal clearance can be screened for study participation.
* Patient currently receiving a 1.0 K+, 3.0 K+ dialysate bath and unwilling to convert to a 2.0 K+/2.5 Ca++ dialysate bath
* Subject unwilling to convert from a 2.0 K+ dialysate bath to a 3.0 K+ dialysate bath
* Two or more pre-dialysis K+ of \< 5.1 or \> 6.5 mEq/L measured by Piccolo POCT after the long dialytic "weekends" during screening Note: If one of the two screening pre-dialysis K+ levels is between 4.6 to 5.0 mEq/L or 6.6 to 7.0 mEq/L, the patient can undergo an additional whole blood Piccolo POCT K+ measurement. Patients who fail the third whole blood Piccolo POCT K+ measurement will be considered ineligible for study participation. Note: Screen failures can be re-screened once to confirm eligibility in the study.
* Any documented whole blood Piccolo POCT K+ measurement that falls below 4.6 mEq/L or exceeds 7.0 mEq/l during the screening period
* Current use of a medication for treatment of hyperkalemia (e.g., Patiromer).
* Note: If a medication for treatment of hyperkalemia is stopped prior to or after the consenting process, the subject will undergo a one week washout prior to the first whole blood Piccolo POCT K+ measurement. Exclusion Criteria Related to Other Medical Conditions and Treatments:
* Anticipated life expectancy of 3 months duration
* Development of atrial fibrillation requiring hospitalization, medical therapy, anticoagulation, or cardioversion during study pre-screening or screening period
* Patient with a known placement of a dual or single chamber pacemaker
* Patient with an automatic implantable cardiac defibrillator (AICD)
* Patient with a LINQ implanted cardiac loop recorder with less than 6 months of battery life.
* Current use of amiodarone or other anti-arrhythmic therapy. Note: Patients on such medications must undergo a two week washout prior to the first whole blood Piccolo POCT K+ measurement.
* Known history of cardiac arrhythmias due to prolonged QT syndrome
* Subject unwilling to receive an implanted LINQ cardiac loop recorder (unless 6 months are remaining in their previously implanted device).
* Known active drug abuse
* Positive hepatitis C polymerase chain reaction (PCR) test with active viral deoxyribonucleic acid (DNA) shedding or chronic active hepatitis B as evidenced by detectable surface antigen from standard of care routine dialysis labs. Note: Patients with negative PCR DNA testing for either hepatitis B or C will be allowed to participate in the study.
* Known to have tested positive for human immunodeficiency virus (HIV) from standard of care routine dialysis labs.
* For women only: currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
* Patients with known and/or active severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders or diabetic gastroparesis Exclusion Criteria Related to the Investigational Product (IP):
* Known hypersensitivity to sodium zirconium cyclosilicate (Lokelmaâ).
Other/General Exclusion Criteria:
* Previous randomization in the present study. Note: Screen failures can be re-screened once to confirm eligibility in the study.
* Participation in another interventional (non-observational) clinical study within 4 weeks prior to enrollment in the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05535920
Study Brief:
Protocol Section:
NCT05535920