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Sodium Zirconium Cyclosilicate for treatment of hyperkalemia in hemodialysis patients: a multi-center, randomized, controlled study

Sodium Zirconium Cyclosilicate for treatment of hyperkalemia in hemodialysis patients: a multi-center, randomized, controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046689
Enrollment
Unknown
Registered
2021-05-26
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Hyperkalemia in hemodialysis patients

Interventions

Experimental group:Sodium Zirconium Cyclosilicate
Control group:Insulin and glucose

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Subject signs informed consent; 2.Female or male, patients >= 18 years of age; 3.Maintenance hemodialysis patients who have been on dialysis for more than three months ; 4.Serum potassium is between 5.5 mmol/L and 6.5 mmol/L .

Exclusion criteria

Exclusion criteria: 1.During screening, hemoglobin14g/dL white blood cells > 20x10^9/L serum calcium < 8.2mg/dL (corrected calcium < 8.0mg/dL) or severe acidosis (serum bicarbonate <= 16mmol/l) ; 2.Have used lactulose, rifaximin, other non-absorbable antibiotics, sodium zirconium cyclic silicate, calcium polystyrene sulfonate, or patronome within 7 days before randomization ; 3.Severe disease, myocardial infarction, acute coronary syndrome (New York Heart Function Classification (NYHA) iii or higher), stroke, seizure or thromboembolic events occurred within 12 weeks before randomization; 4.Patients who cannot take medicines orally; 5.Known allergy or history of allergy to sodium zirconium cyclosilicate or its components; 6.There are contraindications to the use of insulin; 7.Maintenance hemodialysis patients with residual urine volume; 8.Planning or participating in other clinical studies (1 month before screening); 9.The investigator judges that there is a safety risk to the patient or there are other unsuitable conditions.

Design outcomes

Primary

MeasureTime frame
Serum potassium;

Countries

China

Contacts

Public ContactLiu Zhangsuo; Wang Pei

The First Affiliated Hospital of Zhengzhou University

wangpei146@hotmail.com+86 13523467291

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026