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Not yet recruitingNCT06736184Updated Dec 16, 2024

The Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

A Phase 4 interventional study of Sodium Zirconium Cyclosilicate (SZC) in Chronic Kidney Disease on Hemodialysis, Hypokalemia and Hyperkalemia, sponsored by Qianfoshan Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by Qianfoshan Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The management of serum potassium in maintenance hemodialysis(MHD )patients is one of the hot topics at present. In order to control hyperkalemia in dialysis patients, the use of hypokalemic dialysate is the most important measure to reduce potassium. This measure effectively reduces serum potassium, but increases the risk of hypokalemia after dialysis, which increases the risk of all-cause death in patients. Hyperkalemia and hypokalemia during and at the end of dialysis are important factors for arrhythmia and death in MHD patients. Due to the intermittent nature of hemodialysis treatment, MHD patients often experience frequent fluctuations in serum potassium, which is a potential risk factor for poor prognosis of MHD patients. Serum potassium variability can better reflect the potassium homeostasis in MHD patients. In addition to hyperkalemia and hypokalemia, serum potassium variability is a potential risk factor affecting the prognosis of MHD patients. At present, there are few studies on the effect of improving serum potassium variability on cardiovascular complications, especially multi-center randomized controlled trials. In this study, sodium zirconium cyclosilicate was used to control hyperkalemia before dialysis and increase potassium concentration in dialysate, so as to reduce the risk of hypokalemia after dialysis, and to verify whether improving serum potassium variability can reduce myocardial injury in hemodialysis patients.

02

Conditions studied

  • Chronic Kidney Disease on Hemodialysis
  • Hypokalemia
  • Hyperkalemia
  • Myocardial Injury

Keywords

  • maintenance hemodialysis
  • Potassium Variability
  • Myocardial injury
03

In context

Hypokalemia

38 studies on the registry are indexed under Hypokalemia; 5 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 29 interventional studies indexed under Hypokalemia.

Browse Hypokalemia studies →

Lead sponsor

Qianfoshan Hospital is the lead sponsor of 144 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18-75 years old;
  2. Maintenance hemodialysis ≥3 months;
  3. Serum potassium ≥5.0mmol/L and ≤8mmol/L before dialysis;
  4. Have independent ability;
  5. Complete clinical baseline data.

Exclusion criteria

Exclusion Criteria:

  1. Complicated with congenital heart disease, myocardial infarction and other heart diseases that may lead to cardiac dysfunction;
  2. Combined with other serious diseases, such as immune diseases, severe liver and kidney dysfunction;
  3. Unable to cooperate with the researcher due to mental reasons;
  4. If the duration of dialysis is less than 4 hours, severe infection;
  5. Patients with malignant tumors or major mental disorders;

6, except primary cardiomyopathy;

  1. Severe constipation, intestinal obstruction, etc.
  1. other investigators considered that enrollment was not recommended.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Potassium Variability and Myocardial Injury

    Drug: Sodium Zirconium Cyclosilicate (SZC)

  • No intervention
    Control

Interventions

06

What researchers measure

Primary outcomes

  1. Changes in QTcd at the end of dialysis in different observation groups

    Time frame: From enrollment to the end of treatment (totally 12 months)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Pun PH, Middleton JP. Dialysate Potassium, Dialysate Magnesium, and Hemodialysis Risk. J Am Soc Nephrol. 2017 Dec;28(12):3441-3451. doi: 10.1681/ASN.2017060640. Epub 2017 Oct 9. PubMed 28993507 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06736184
Responsible party
Zunsong Wang (Chief of Nephrology Department, Qianfoshan Hospital) — Principal investigator
First posted
Dec 16, 2024
Start date
Mar 1, 2025 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 16, 2024

Study contacts

zunsong Wang
Contact
wzsong3@163.com
86+053189269107

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Sodium zirconium cyclosilicate

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