Effects of Sodium Zirconium Cyclosilicate on Quality Of Life in patients with hyperkalemia undergoing hemodialysis (Y-QOL study)
Effects of Sodium Zirconium Cyclosilicate on Quality Of Life in patients with hyperkalemia undergoing hemodialysis (Y-QOL study)
Wakui Hiromichi
Yokohama City University Hospital
3-9 Fukuura, Kanazawa-ku
+81-457872511
hiro1234@yokohama-cu.ac.jp
Kanai Daisuke
Yokohama City University
3-9 Fukuura, Kanazawa-ku
+81-45-787-2511
kanai.dai.ty@yokohama-cu.ac.jp
Not Recruiting
Jan. 15, 2024
Jan. 24, 2024
200
Interventional
randomized controlled trial
open(masking not used)
no treatment control/standard of care control
parallel assignment
treatment purpose
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 the prescribed dialysis conditions (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) are not scheduled to change any of the conditions during the study period
7. Patients are not scheduled to change the type of anticoagulant on HD 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.
1. Patients whose serum potassium value, determined from a blood sample taken just before the implementation of the initial HD session in the week (i.e., pre-HD serum potassium value after the LIDI), are >= 6.5 mEq/L up to 1 week prior to case enrollment
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 medium dose (guideline: Prednisolone (PREDONINE) equivalent 7.5 mg/day higher) or immunosuppressants
6. Patients who are certified as a needed long-termcare 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 kidneytransplant 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
20age old over
No limit
Both
Chronic kidney disease
Administrarion of Sodium Zirconium Cyclosilicate (Lokelma) in the intervention group.
Changes in QDIS-7 scores (indicating QOL related to dietary potassium intake restriction) at Week 8 from baseline in intervention group, control group, respectively.
[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, intake of each food group (e.g., vegetables, fruits, meat, grains), and potassium intake from each food group (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
AstraZeneka
Yokohama City University Certified Institutional Review Board
