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Comparison of the efficacy and safety of thiazide diuretics calcium polystyrene sulfonate and sodium zirconium cyclosilicate in treating hyperkalemia in patients with chronic kidney disease: a randomized controlled trial

Comparison of the efficacy and safety of thiazide diuretics calcium polystyrene sulfonate and sodium zirconium cyclosilicate in treating hyperkalemia in patients with chronic kidney disease: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250519005
Enrollment
75
Registered
2025-05-19
Start date
2025-04-17
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Chronic kidney disease stages 3 to 5 with chronic hyperkalemia Hyperkalemia Kidney Diseases, Chronic Diuretics, Thiazide Sodium Zirconium Cyclosilicate Polystyrenes Potassium

Interventions

Participants in the SZC group will receive sodium zirconium cyclosilicate 5 grams once daily orally after breakfast for 14 days. Dose may be adjusted on day 7 based on serum potassium.,Participants in
Sodium Zirconium Cyclosilicate ,Calcium polystyrene sulfonate ,Hydrochlorothiazide

Sponsors

Ratchadapisek Research Funds (Type I)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age 18 years or older 2.Diagnosed with chronic kidney disease stage 3 to 5 with eGFR less than 60 mL per min per 1 point 73 square meter 3.Serum potassium between 4 point 8 and 5 point 9 mmol per liter 4.Serum bicarbonate between 18 and 24 mmol per liter 5.No use of diuretics or calcium polystyrene sulfonate within 14 days before enrollment

Exclusion criteria

Exclusion criteria: 1.On hemodialysis or peritoneal dialysis 2.Kidney transplant recipient 3.Active gastrointestinal infection 4.Serum potassium greater than 6 mmol per liter 5.Electrocardiogram with significant abnormalities such as peaked T waves or wide QRS 6.Heart rate less than 60 or greater than 150 beats per minute 7.Systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mmHg 8.Active malignancy 9.Pregnancy 10.History of severe allergy to study medications 11.Serum uric acid greater than 13 mg per dL 12.Acute gout attack 13.Suspected pseudohyperkalemia

Design outcomes

Primary

MeasureTime frame
Change in serum potassium level from baseline to day 7 7 days after treament mmol/L

Secondary

MeasureTime frame
Change in serum potassium level from baseline to day 14 14 days after treatment mmol/L,Proportion of participants achieving normal serum potassium at day 7 7 days after treatment percentage,Proportion of participants achieving normal serum potassium at day 14 14 days after treatment percentage,Change in serum bicarbonate level from baseline to day 7 7 days after treatment meq/L,Change in serum bicarbonate level from baseline to day 14 14 days after treatment meq/L,Change in gastrointestinal symptoms assessed by GSRS from baseline to day 7 7 days after treatment 7 points likert scale,Change in gastrointestinal symptoms assessed by GSRS from baseline to day 14 14 days after treatment 7 points likert scale,Incidence of adverse events up to day 14 14 days after treatment Number and type of adverse events reported by participants or observed by investigators.

Countries

Thailand

Contacts

Public ContactJathurong Kittrakulrat

Faculty of Medicine, Chulalongkorn University

j.kittrakulrat@gmail.com022564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026