Potassium ImbalancePhase 4NCT06242041
The Effect of Potassium Lowering Drugs on Cardiac Electrical Stability in Hemodialysis Patients (ART Study)
A Phase 4 study testing sodium zirconium cyclic silicate in people with Potassium Imbalance and Cardiac Arrhythmia, run by Peking University First Hospital at 1 site in China.
Trial summary
This study is a multicenter, prospective and randomized controlled study. The experiment includes a 1-week screening period (1 week before dialysis) and a 7-week treatment period (1-4 weeks of dose drip period and 5-7 weeks of evaluation period). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Potassium Imbalance, Cardiac Arrhythmia, Dialysis; Complications
- What is being tested?
- sodium zirconium cyclic silicate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2022to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years old.
- ESKD received hemodialysis treatment three times a week for more than 3 months.
- After a long interval, before dialysis, the serum potassium was≥5.0mmol/L and was examined for two months in a row.
- Screening patients with serum potassium≥5.0mmol/L before dialysis.
Who cannot join
- poor compliance with dialysis treatment.
- Acute myocardial infarction, acute coronary syndrome, stroke, epilepsy or thromboembolism (such as deep vein thrombosis or pulmonary embolism, but excluding hemodialysis pathway thrombosis) occurred within 12 weeks before the screening date.
- Hypokalemia (blood potassium<3.5mmol/L), hypocalcemia (blood calcium<2.1mmol/L), hypocalcemia (blood magnesium<0.7mmol/L) or severe acidosis (blood bicarbonate<16mmol/L) occurred within 4 weeks before the screening date.
- Severe hematological abnormalities: white blood cells>20×10^9/L, platelets≥450×10^9/L.
- Rhabdomyolysis was diagnosed 4 weeks before screening.
- Taking lactulose, rifaximin or other unabsorbed antibiotics to treat hyperammonemia within 7 days before taking the first medicine.
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- Patients cannot take sodium zirconium silicate orally.
- The patient is allergic to sodium zirconium silicate or other components of the drug.
- The life expectancy of patients is less than 1 year.
- Patients during pregnancy and lactation.
- Female patients preparing for pregnancy during the study period.
- Participated in clinical research of other drugs in the month before screening.
- Persons who have lost their autonomous capacity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University first hospital hemodialysis center
Beijing, Beijing Municipality, 100000
LI LIU, 13601015233, cutewise@163.com
About this study
Official title: The Effect of Potassium Lowering Drugs on Cardiac Electrical Stability in Hemodialysis
This study is a multicenter, prospective and randomized controlled study. The experiment includes a 1-week screening period (1 week before dialysis) and a 7-week treatment period (1-4 weeks of dose drip period and 5-7 weeks of evaluation period). During the screening period, all patients were randomly divided into the control group and the treatment group. On the non-dialysis day of the treatment period, the treatment group was given a certain dose of sodium zirconium silicate, and the blood potassium value was measured before and after each dialysis to maintain the blood potassium at 4.0-5.0mmol/L before dialysis. At the same time, 12-lead ECG and 24-hour Holter were completed at the first and last dialysis during the treatment period, and finally the ECG stability and its relationship with blood potassium were evaluated.
Read the detailed description
- Screening period (1 week before administration): After 72 hours without dialysis treatment and before dialysis for the first time, complete the set 1 of laboratory inspection group, including hemoglobin, white blood cells, platelets, serum creatinine, urea nitrogen, alanine aminotransferase, aspartate aminotransferase, albumin, potassium, calcium, magnesium and bicarbonate. After dialysis, complete the set 2 of laboratory inspection group, including urea nitrogen and potassium. According to the ratio of 1: 1, the patients were randomly divided into control group (routine treatment) and experimental group (sodium zirconium silicate was given on the basis of routine treatment).
- Dose drops period (1st week to 4th week):
Blood samples are collected before and after dialysis for the first time every week to complete the set 3 of laboratory inspection group, including: potassium, and the dosage of SZC is adjusted according to the blood potassium value, which is administered on non-dialysis days, four times a week, starting from 5g/day each time, and the blood potassium before dialysis is maintained at 4.0-5.0mmol/L, which can be adjusted at 10g/week each time, and the highest dosage can be increased to 80g/week.
- If the blood potassium is higher than 5.0mmol/L during the follow-up, the amount of SZC can be gradually increased to 30-80g per week.
- If during the follow-up, the blood potassium before dialysis is lower than 5mmol/L, and the potassium concentration of dialysate is raised to 3mmol/L, other ion concentrations remain unchanged, including calcium, bicarbonate, sodium and magnesium. If the blood potassium is still below 5mmol/L in the follow-up, the SZC will be reduced to 10g per week. If the blood potassium is lower than 4.0mmol/L in the follow-up, stop the experiment.
In the first week of drip period, 12-lead ECG and Holter were completed on the day of dialysis.
3.Evaluation period (week 5 to week 7): At the end of the experiment, blood was collected before the last dialysis to complete the laboratory inspection group set 1, and the 12-lead electrocardiogram was improved and Holter was worn, while blood was collected after dialysis to complete the laboratory inspection group set 2.
- Being tested
- sodium zirconium cyclic silicate
- Keywords
- Hyperkalemia, Chronic kidney disease, Maintenance hemodialysis, cardiac electrical stability, New oral potassium-lowering drugs, T wave alternans
- Medical subject headings
- Arrhythmias, Cardiac, Hyperkalemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium zirconium cyclic silicateDrug
Also called hemodialysis
On the non-dialysis day, the drug was given to patients in the treatment group, four times a week, starting from 5g/day each time, and the blood potassium before dialysis was maintained at 4.0-5.0mmol/L, which could be adjusted at 10g/week each time, and the highest dose could be increased to 80g/ week.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Routine treatment, and on the non-dialysis day, sodium zirconate silicate is given four times a week, starting from 5g/ day each time, and the blood potassium before dialysis is maintained at 4.0-5.0mmol/L, which can be adjusted by 10g/ week each time, and the highest dose can be increased to 80g/ week. Receives: Drug: sodium zirconium cyclic silicate |
| Control group | Placebo comparator | Routine treatment. Receives: Drug: sodium zirconium cyclic silicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potassium lowering effect
The decrease of serum potassium in the treatment group before dialysis after using sodium zirconium silicate was compared with that in the control group.
Measured: 7 weeks.
Changes of ECG stability during dialysis.
To compare the changes of ECG activity between the treatment group and the control group during dialysis after potassium reduction treatment.
Measured: 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start14 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potassium ImbalanceStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Parallel groups
- Model description
- Treatment group: routine treatment, and oral potassium reduction by SZC on non-dialysis day. Control group: routine treatment.
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li LIU, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242041
- Sponsor's protocol ID
- 2022CR08
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Potassium Lowering Drugs on Cardiac Electrical Stability in Hemodialysis
- ClinicalTrials.gov ID
- NCT06242041
- Acronym / sponsor ID
- 2022CR08
- Keywords
- Hyperkalemia, Chronic kidney disease, Maintenance hemodialysis, cardiac electrical stability, New oral potassium-lowering drugs, T wave alternans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Feb 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.
This study is a multicenter, prospective and randomized controlled study. The experiment includes a 1-week screening period (1 week before dialysis) and a 7-week treatment period (1-4 weeks of dose drip period and 5-7 weeks of evaluation period). During the screening period, all patients were randomly divided into the control group and the treatment group. On the non-dialysis day of the treatment period, the treatment group was given a certain dose of sodium zirconium silicate, and the blood potassium value was measured before and after each dialysis to maintain the blood potassium at 4.0-5.0mmol/L before dialysis. At the same time, 12-lead ECG and 24-hour Holter were completed at the first and last dialysis during the treatment period, and finally the ECG stability and its relationship with blood potassium were evaluated.
Detailed description
- Screening period (1 week before administration): After 72 hours without dialysis treatment and before dialysis for the first time, complete the set 1 of laboratory inspection group, including hemoglobin, white blood cells, platelets, serum creatinine, urea nitrogen, alanine aminotransferase, aspartate aminotransferase, albumin, potassium, calcium, magnesium and bicarbonate. After dialysis, complete the set 2 of laboratory inspection group, including urea nitrogen and potassium. According to the ratio of 1: 1, the patients were randomly divided into control group (routine treatment) and experimental group (sodium zirconium silicate was given on the basis of routine treatment).
- Dose drops period (1st week to 4th week):
Blood samples are collected before and after dialysis for the first time every week to complete the set 3 of laboratory inspection group, including: potassium, and the dosage of SZC is adjusted according to the blood potassium value, which is administered on non-dialysis days, four times a week, starting from 5g/day each time, and the blood potassium before dialysis is maintained at 4.0-5.0mmol/L, which can be adjusted at 10g/week each time, and the highest dosage can be increased to 80g/week.
- If the blood potassium is higher than 5.0mmol/L during the follow-up, the amount of SZC can be gradually increased to 30-80g per week.
- If during the follow-up, the blood potassium before dialysis is lower than 5mmol/L, and the potassium concentration of dialysate is raised to 3mmol/L, other ion concentrations remain unchanged, including calcium, bicarbonate, sodium and magnesium. If the blood potassium is still below 5mmol/L in the follow-up, the SZC will be reduced to 10g per week. If the blood potassium is lower than 4.0mmol/L in the follow-up, stop the experiment.
In the first week of drip period, 12-lead ECG and Holter were completed on the day of dialysis.
3.Evaluation period (week 5 to week 7): At the end of the experiment, blood was collected before the last dialysis to complete the laboratory inspection group set 1, and the 12-lead electrocardiogram was improved and Holter was worn, while blood was collected after dialysis to complete the laboratory inspection group set 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment group: routine treatment, and oral potassium reduction by SZC on non-dialysis day. Control group: routine treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: sodium zirconium cyclic silicateRoutine treatment, and on the non-dialysis day, sodium zirconate silicate is given four times a week, starting from 5g/ day each time, and the blood potassium before dialysis is maintained at 4.0-5.0mmol/L, which can be adjusted by 10g/ week each time, and the highest dose can be increased to 80g/ week. |
| Control group | Placebo comparator | Drug: sodium zirconium cyclic silicateRoutine treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18 years old.
- ESKD received hemodialysis treatment three times a week for more than 3 months.
- After a long interval, before dialysis, the serum potassium was≥5.0mmol/L and was examined for two months in a row.
- Screening patients with serum potassium≥5.0mmol/L before dialysis.
Key exclusion criteria (13 listed)
- poor compliance with dialysis treatment.
- Acute myocardial infarction, acute coronary syndrome, stroke, epilepsy or thromboembolism (such as deep vein thrombosis or pulmonary embolism, but excluding hemodialysis pathway thrombosis) occurred within 12 weeks before the screening date.
- Hypokalemia (blood potassium<3.5mmol/L), hypocalcemia (blood calcium<2.1mmol/L), hypocalcemia (blood magnesium<0.7mmol/L) or severe acidosis (blood bicarbonate<16mmol/L) occurred within 4 weeks before the screening date.
- Severe hematological abnormalities: white blood cells>20×10^9/L, platelets≥450×10^9/L.
- Rhabdomyolysis was diagnosed 4 weeks before screening.
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 cyclic silicateAlso: hemodialysisOn the non-dialysis day, the drug was given to patients in the treatment group, four times a week, starting from 5g/day each time, and the blood potassium before dialysis was maintained at 4.0-5.0mmol/L, which could be adjusted at 10g/week each time, and the highest dose could be increased to 80g/ week. | Drug | Control group, Treatment group |
Primary outcome
Potassium lowering effect
Time frame: 7 weeks.
The decrease of serum potassium in the treatment group before dialysis after using sodium zirconium silicate was compared with that in the control group.
Changes of ECG stability during dialysis.
Time frame: 7 weeks.
To compare the changes of ECG activity between the treatment group and the control group during dialysis after potassium reduction treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium zirconium cyclic silicate in people with Potassium Imbalance and Cardiac Arrhythmia, run by Peking University First Hospital at 1 site in China.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LI LIU (13601015233, cutewise@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potassium lowering effect (time frame: 7 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2024.