A Comparative Study of Improvement of Hyperkalemia by Sodium Zirconium Cyclosilicate Hydrate and Polystyrene Sulfonate Calcium in Chronic Hemodialysis Patients (Multicenter collaborative study)

A Comparative Study of Improvement of Hyperkalemia by Sodium Zirconium Cyclosilicate Hydrate and Polystyrene Sulfonate Calcium in Chronic Hemodialysis Patients (Multicenter collaborative study) - A study of improving pre-dialysis hyperkalemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042090

Enrollment

100

Registered

2020-10-12

Start date

2020-10-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage renal disease requiring maintenance hemodialysis

Interventions

Sodium zirconium cyclosilicate hydrate: Suspend 5 g in water per day and give 1 once per day on non-dialysis days. The drug administration period is one month. Polystyrene sulfonate calcium: As 1 da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Chronic maintenance hemodialysis patients receiving hemodialysis therapy three times per week 2. Patients with pre-dialysis serum potassium levels of 5.6 mEq/L or higher or receiving treatment for hyperkalemia by potassium adsorbents 3. Patients who personally provided written consent at their own free will to participate in this study after receiving a thorough explanation and providing informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with an allergy to sodium zirconium cyclosilicate hydrate or polystyrene sulfonate calcium 2. Patients with intestinal stenosis or severe constipation 3. Patients who are pregnant or breastfeeding 4. Patients who participated in another clinical trial (study) less than three months prior to commencing the test drug Grounds for setting the exclusion criteria: 1 - 3 are in consideration of safety and 4 is in consideration of the effect on the efficacy evaluation and safety

Design outcomes

Primary

Measure	Time frame
The proportion of responders will be compared between the SZC group and CPS group. Responders: Among pre-dialysis K levels measured four times at the beginning of the week while using the allocated drug, those with serum K levels within the range of >=4.0 mEq/L and <=5.0 mEq/L at least three times will be defined as responders.	—

Secondary

Measure	Time frame
1. We will conduct an intergroup comparison of the amount of change in serum zinc, serum copper, and shunt blood bicarbonate ion concentrations from before to after usage of the allocated drug. 2. We will conduct an intergroup comparison of serum zinc, serum copper, shunt blood bicarbonate ion concentrations, PAC-QOL scores during usage of the allocated drug, and the rate of weight gain in dialysis intervals (=dialysis interval weight gain/ dry weight) 3. Drug side effects	—

Measure

Time frame

1. We will conduct an intergroup comparison of the amount of change in serum zinc, serum copper, and shunt blood bicarbonate ion concentrations from before to after usage of the allocated drug. 2. We will conduct an intergroup comparison of serum zinc, serum copper, shunt blood bicarbonate ion concentrations, PAC-QOL scores during usage of the allocated drug, and the rate of weight gain in dialysis intervals (=dialysis interval weight gain/ dry weight) 3. Drug side effects

—

Countries

Japan

Contacts

Public ContactKeiji Fujimoto

Kanazawa Medical University Nephrology

k-2210@kanazawa-med.ac.jp076-286-2211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026