JPRN-jRCTs031230404RecruitingUnknown
Effects of Sodium Zirconium Cyclosilicate on Quality Of Life in patients with hyperkalemia undergoing hemodialysis - Y-QOL study
Wakui Hiromichi0 sites200 target enrollmentStarted: January 15, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1. Patients who are able to give a written informed consent for participation in the study
- •2. Patients aged 20 years or older
- •3. Patients whose serum potassium value determined from a blood sample taken just before implementation of the initial HD in the week, i.e., pre-HD serum potassium value after the LIDI, is >= 5.5 mEq/L at least once during the screening period
- •4. Patients with end-stage renal failure who have been on periodic HD therapy 3 times weekly for at least 3 months before randomization
- •5. Patients who have had HD access of an arteriovenous (AV) fistular or AV graft, tunneled catheter indwelt for a long-term use, and are not going to change the current vascular access during the study period
- •6. Patients for whom no change has been made in the conditions for prescribed dialysis (i.e., the duration of dialysis per session, frequency of dialysis therapy per week, intervals between dialysis treatments, dialysate flow rate, blood flow rate, dialyzer used, and vascular access) for the last 3 months, and who are not going to change any of the conditions during the study period
- •7. Patients who have not changed the dose of an anticoagulant, if used, during HD for the last 3 months, and are not going to change it during the study period
- •8. Patients who are expected by the physician in charge of dialysis therapy to receive dietary guidance from the registered dietitian or dietician on a regular basis and practice what is guided in their daily life
- •9. Patients who are not planned to have the dosage of RAS inhibitors altered during the study.
Exclusion Criteria
- •1. Patients whose serum potassium levels become >= 6.5 mEq/L during the screening period
- •2. Patients for whom pseudo-hyperkalemia due to hemolysis is suspected
- •3. Patients who have any of the following disorders:
- •3.1. Cognitive impairment
- •3.2. Polycythemia
- •3.3. Malignant tumor under treatment
- •3.4. Infectious disorder under treatment
- •3.5. Potentially fatal arrhythmias such as pre-treatment ventricular fibrillation, ventricular tachycardia, and high-degree atrioventricular block (including cases that are unstable during or after treatment)
- •3.6. Hyperammonemia which has occurred within 7 days of the first dose of SZC and has been treated with non-absorbable antibiotics (e.g., lactulose, Xifaxan (rifaximin))
- •3.7. Rhabdomyolysis which has occurred within 4 weeks before randomization
- •3.8. Hypokalemia (with serum potassium levels lower than 3.5 mEq/L) which has occurred within 4 weeks before randomization
- •3.9. Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event which has occurred within 8 weeks before randomization
- •3.10. A history of alcohol or drug abuse within 2 years before randomization
- •4. Patients who orally take potassium adsorbents during the screening period
- •5. Patients who are on oral treatment with steroids or immunosuppressants
- •6. Patients who are certified as a needed long-term care level of 3 or higher under the Japan's long-term care insurance system
- •7. Patients whose hemoglobin levels are < 9 g/dL at screening
- •8. Patients who have not complied with HD prescription during the 1-week period before screening
- •9. Patients who have been hospitalized within one month of the study initiation
- •10. Patients who are scheduled to be hospitalized during the study period
- •11. Patients who are scheduled to undergo a kidney transplant from a living donor during the study period
- •12. Patients who have known allergy or hypersensitivity to SZC
- •13. Patients who are unable to orally take SZC
- •14. Patients with a life expectancy of less than 6 months
- •15. Female patients who are or are scheduled to be pregnant or breastfeeding
- •16. Females of childbearing potential who will not use contraception or sexual abstinence
- •17. Patients who are judged by the investigator to be ineligible for the study
Investigators
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