Chronic Kidney Disease on HemodialysisPhase 4NCT06736184
the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
A Phase 4 study testing Sodium Zirconium Cyclosilicate (SZC) in people with Chronic Kidney Disease on Hemodialysis and Hypokalemia, run by Qianfoshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease on Hemodialysis, Hypokalemia, Hyperkalemia
- What is being tested?
- Sodium Zirconium Cyclosilicate (SZC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old;
- Maintenance hemodialysis ≥3 months;
- Serum potassium ≥5.0mmol/L and ≤8mmol/L before dialysis;
- Have independent ability;
- Complete clinical baseline data.
Who cannot join
- Complicated with congenital heart disease, myocardial infarction and other heart diseases that may lead to cardiac dysfunction;
- Combined with other serious diseases, such as immune diseases, severe liver and kidney dysfunction;
- Unable to cooperate with the researcher due to mental reasons;
- If the duration of dialysis is less than 4 hours, severe infection;
- Patients with malignant tumors or major mental disorders;
- 6, except primary cardiomyopathy;
- 7. Severe constipation, intestinal obstruction, etc.
- 8. other investigators considered that enrollment was not recommended.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Multicenter Randomized Controlled Trial on the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
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.
- Being tested
- Sodium Zirconium Cyclosilicate (SZC)
- Keywords
- maintenance hemodialysis, Potassium Variability, Myocardial injury
- Medical subject headings
- Hypokalemia, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Zirconium Cyclosilicate (SZC)Drug
5g/meal*3meals/day
| Study group | Role | What they receive |
|---|---|---|
| Potassium Variability and Myocardial Injury | Experimental | Not described Receives: Drug: Sodium Zirconium Cyclosilicate (SZC) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in QTcd at the end of dialysis in different observation groups
Measured: From enrollment to the end of treatment (totally 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease on HemodialysisStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zunsong Wang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736184
- Sponsor's protocol ID
- CEIPV-MHD
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Trial on the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06736184
- Acronym / sponsor ID
- CEIPV-MHD
- Keywords
- maintenance hemodialysis, Potassium Variability, Myocardial injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Variability and Myocardial Injury | Experimental | Drug: Sodium Zirconium Cyclosilicate (SZC) |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years old;
- Maintenance hemodialysis ≥3 months;
- Serum potassium ≥5.0mmol/L and ≤8mmol/L before dialysis;
- Have independent ability;
- Complete clinical baseline data.
Key exclusion criteria (8 listed)
- Complicated with congenital heart disease, myocardial infarction and other heart diseases that may lead to cardiac dysfunction;
- Combined with other serious diseases, such as immune diseases, severe liver and kidney dysfunction;
- Unable to cooperate with the researcher due to mental reasons;
- If the duration of dialysis is less than 4 hours, severe infection;
- Patients with malignant tumors or major mental disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Zirconium Cyclosilicate (SZC)5g/meal*3meals/day | Drug | Potassium Variability and Myocardial Injury |
Primary outcome
Changes in QTcd at the end of dialysis in different observation groups
Time frame: From enrollment to the end of treatment (totally 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Results publication: PubMed 28993507Pun 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Zirconium Cyclosilicate (SZC) in people with Chronic Kidney Disease on Hemodialysis and Hypokalemia, run by Qianfoshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zunsong Wang (86+053189269107, wzsong3@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in QTcd at the end of dialysis in different observation groups (time frame: From enrollment to the end of treatment (totally 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.