Sodium Zirconium Cyclosilicate (SZC) for Hyperkalemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Bratislava, Slovakia
Hyperkalemia
Sodium Zirconium Cyclosilicate (SZC) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication may help reduce the risk of heart problems in individuals on dialysis.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Sodium Zirconium Cyclosilicate (SZC) will improve 2 primary outcomes, 11 secondary outcomes, and 3 other outcomes in patients with Hyperkalemia. Measurement will happen over the course of Evaluated at 12 months after randomization.

Month 12
S-K > 6.5 mmol/L (yes/no) after the LIDI at the 12 month visit
S-K of 4.0-5.5 mmol/L (yes/no) after the long interdialytic interval (LIDI) at the 12 month visit
Year 2
Change in interdialytic weight gain (kg) as compared to baseline
Events of pre-dialysis hypokalemia (S-K < 3.0 mmol/L)
Number of hospitalizations/interventions/ED visits due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.])
Number of hospitalizations/interventions/ED visits due to arrhythmias (AF, bradycardia, asystole, or VT)
Time to SCD
Time to cardiovascular (CV) death
Time to death of any cause
Time to first instance of rescue therapy use for hyperkalemia
Time to first occurrence of SCD, stroke, or hospitalization/intervention/ED visit due to arrhythmias (atrial fibrillation [AF], bradycardia, asystole, ventricular tachyarrhythmia [VF, VT, etc.])
Time to first occurrence of SCD, stroke, or hospitalization/intervention/ED visit due to arrhythmias (atrial fibrillation [AF], bradycardia, asystole, ventricular tachyarrhythmias [VT])
Time to first occurrence of hospitalization/intervention/ED visit due to arrhythmias (AF, bradycardia, asystole, VT)
Time to first occurrence of hospitalization/intervention/ED visit due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.])
Time to first occurrence of stroke
Year 2
Adverse Events (AEs)/ Serious Adverse Events (SAEs)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Sodium Zirconium Cyclosilicate
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 2300 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sodium Zirconium Cyclosilicate (SZC) is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Sodium Zirconium Cyclosilicate
Drug
Placebo
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization visit through study completion during study visits every 3 months, over an average of 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomization visit through study completion during study visits every 3 months, over an average of 2 years for reporting.

Closest Location

Research Site - Kansas City, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Hyperkalemia. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses
Must be ≥ 18 years of age, at the time of signing the ICF. For participants < 20 years of age and enrolled in Japan, a written informed consent should be obtained from the participant and his or her legally acceptable representative
Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of ESRD for ≥ 4 months before enrollment
Must have hemodialysis access consisting of an arteriovenous fistula, arteriovenous graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study
At least 2 out of 3 pre-dialysis S K ≥ 5.5 mmol/L after the LIDI during screening
Negative pregnancy test for female participants of childbearing potential
Female participants must be 1 year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose

Patient Q&A Section

How serious can hyperkalemia be?

"In severe cases, mortality can be as high as 20%. Hyperkalemia represents an extremely serious condition and, thus, deserves serious attention in the management of hyperkalemia." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hyperkalemia?

"Symptoms and signs of hyperkalemia may seem similar to those of other cardiovascular complications in patients with diabetes. Clinical symptoms vary significantly, even when patients with diabetes mellitus are treated for hypovolemic acidosis." - Anonymous Online Contributor

Unverified Answer

What is hyperkalemia?

"Hyperkalemia is a common electrolyte imbalance which can occur with and without metabolic acidosis. Symptoms can vary between patients based on the specific type of hyperkalemia. Hyperkalemia can occur in a single case of electrolyte imbalance, or over long periods of time with no changes in other electrolyte levels. Hyperkalemia is one of the most common electrolyte abnormalities. Treatment depends on the severity of the condition and can require intravenous calcium supplementation, potassium binder medications, or insulin therapy. The most common hyperkalemia is an abnormal shift of potassium ions from extracellular fluid into the blood. Symptoms are generally low blood pressure, muscle weakness, spasm, low blood pH, and other disturbances." - Anonymous Online Contributor

Unverified Answer

What are the signs of hyperkalemia?

"Hyperkalemia is characterized by elevated blood potassium levels in the range of 6.5 mEq/L to 9.0 mEq/L. Symptoms of hyperkalemia are often vague and may or may not be present. Abnormalities on an electrocardiogram are not necessarily found in all cases of hyperkalemia." - Anonymous Online Contributor

Unverified Answer

What causes hyperkalemia?

"The cause of hyperkalemia is many-fold. The most common causes are those which occur in kidney failure, including those due to impaired sodium and water excretion from the kidneys. Other causes are due to cardiac problems and metabolic acidosis. In the absence of kidney disease, hyperkalemia has many causes, including drug use and certain types of tumor. It usually requires a different evaluation and treatment. Hyperkalemia is an important prognostic marker of poor outcome and, thus, should be measured in patients with high risk. Future research is required to identify more reliable risk factors." - Anonymous Online Contributor

Unverified Answer

Can hyperkalemia be cured?

"Hyperkalemia can be cured if treatment is started early. Patients who do not respond to medical therapy at the hospital can be treated at home with an implantable cardiac rhythm device and low dose (3.6 mEq/kg/d) potassium supplementation. Hyperkalemia will almost spontaneously and completely resolve after one week of outpatient maintenance of normokalaemic normotensive patients." - Anonymous Online Contributor

Unverified Answer

How many people get hyperkalemia a year in the United States?

"About 8% of American adults have hyperkalemia during the year. The overall occurrence of hyperkalemia is increased in females and those with more physician office visits." - Anonymous Online Contributor

Unverified Answer

Has sodium zirconium cyclosilicate (szc) proven to be more effective than a placebo?

"The present study provides evidence for a superiority of SZC over a placebo, particularly regarding (1) a marked prolongation of the QT interval intervals, and (2) reduction of elevated serum potassium levels." - Anonymous Online Contributor

Unverified Answer

What does sodium zirconium cyclosilicate (szc) usually treat?

"Although szc has been reported as effective in treating hyperkalemia due to CKD and chronic diarrhea, this study reports no evidence of improvement in any of the indications for treatment other than for CKD related hyperkalemia." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving sodium zirconium cyclosilicate (szc)?

"This article presents one of several clinical trials involving the use of sodium zirconium cyclosilicate. Despite having some methodological problems, we believe that it can be useful as an adjuvant therapy to the already existing treatments in patients with chronic hyperkalemic periodic paralysis. More studies with large sample size and randomized trials are needed to corroborate these preliminary results." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of sodium zirconium cyclosilicate (szc)?

"Most side effects occur frequently, but are only occasional. These side effects are only moderate in severity, and are mostly not serious. The most common side reactions, mainly rash and fever, have been well documented. Zirconium is a rare metal, and toxicity has not been reported." - Anonymous Online Contributor

Unverified Answer

Is sodium zirconium cyclosilicate (szc) safe for people?

"The data in this study demonstrate a safety/efficacy ratio of >2:1 (e.g., more than twice as expensive and effective as generic versions). These data should be interpreted cautiously until others report their results in a peer-reviewed, randomized study in patient populations with different clinical endpoints. Clinical trial number: NCT02474450 (www.clinicaltrial.gov)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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