Effects of Sodium Zirconium Cyclosilicate on Quality Of Life in patients with hyperkalemia undergoing hemodialysis

JRCT ID: jRCTs031230404

Registered date:15/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 24/01/2024
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Administrarion of Sodium Zirconium Cyclosilicate (Lokelma) in the intervention group.

Outcome(s)

• Primary Outcome: Changes in QDIS-7 scores (indicating QOL related to dietary potassium intake restriction) at Week 8 from baseline in intervention group, control group, respectively.

Secondary Outcome

[QOL]
QDIS-7 scores at Week 8 in intervention group and control group, respectively.

Regarding the items listed below, changes between Week 0 and Week 8 as well as values at Week 8 will be evaluated and compared between the intervention group and the control group and values at Week 0 and Week 8 will be evaluated and compared in each group.
[QOL]
The Kidney Disease Quality of Life instrument KDQOL-SF version 1.3
Questionnaire regarding the subject's sense of burden associated with dietary restriction
General Transition Questionnaire (to be carried out at Week 8 only)
[Nutritional status indicators]
Serum albumin values (Alb)
modified PEW
Dry weight
BMI
GNRI
Total calorie intake, potassium intake, protein intake, salt intake, phospholipid intake, and dietary fiber intake (which will be calculated from dietary records)

[Inflammation]
C-reactive protein (CRP), Interleukin-6 (IL-6)

[Bowel movement]
Britstol Stool Form Scale

[Potassium reducing effect]
Serum potassium values (measured from blood sampling taken just before implementation of the initial HD in the week concerned (after LIDI))

[Body fluid volume Evaluation]
Pro-BNP (just before the initial HD in the week), hANP (after the initial HD in the week)
Cardiothoracic ratio

Regarding the items listed below, cumulative percentages and confidence intervals will be calculated.
[Proportion of study subjects requiring rescue therapy]
Proportion of study subjects requiring rescue therapy due to hyperkalemia or hypokalemia

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Wakui Hiromichi
• Source(s) of Monetary Support: AstraZeneka