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Electrolyte Modifying Agent

SZC for Hyperkalemia

Phase 3
Waitlist Available
Led By Steven Fishbane, Professor, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization visit through study completion during study visits every 3 months, over an average of 3 years
Awards & highlights

Study Summary

This trial will study whether SZC can help improve cardiovascular outcomes for those with hyperkalemia on hemodialysis.

Who is the study for?
This trial is for adults on chronic hemodialysis for end-stage renal disease (ESRD) who have recurrent high potassium levels. They must be dialyzing regularly for at least 4 months and have stable vascular access. Women should use effective birth control or be postmenopausal. Exclusions include recent use of certain potassium binders, urgent atrial fibrillation, significant infections, liver disease, long QT syndrome, pacemakers/defibrillators, or known allergies to SZC.Check my eligibility
What is being tested?
The study tests if Sodium Zirconium Cyclosilicate (SZC), a drug that helps remove excess potassium from the body, can reduce heart rhythm problems in people with high potassium levels due to kidney failure on dialysis compared to a placebo (a substance with no active drug).See study design
What are the potential side effects?
Possible side effects of SZC may include swelling in the limbs, low blood pressure during dialysis sessions, gastrointestinal issues like nausea or constipation, and changes in blood chemistry which might affect muscle and nerve function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization visit through study completion during study visits every 3 months, over an average of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization visit through study completion during study visits every 3 months, over an average of 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.])
Secondary outcome measures
Number of hospitalizations/interventions/ED visits due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.])
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
+6 more
Other outcome measures
Adverse Events (AEs)/ Serious Adverse Events (SAEs)
Change in interdialytic weight gain (kg) as compared to baseline
Events of pre-dialysis hypokalemia (S-K < 3.0 mmol/L)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium Zirconium CyclosilicateExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,591,088 Total Patients Enrolled
31 Trials studying Hyperkalemia
70,100 Patients Enrolled for Hyperkalemia
Steven Fishbane, Professor, MDPrincipal InvestigatorNorth Shore University Hospital, 300 Community Drive, Manhasset, NY 11030

Media Library

Sodium Zirconium Cyclosilicate (SZC) (Electrolyte Modifying Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04847232 — Phase 3
Hyperkalemia Research Study Groups: Placebo, Sodium Zirconium Cyclosilicate
Hyperkalemia Clinical Trial 2023: Sodium Zirconium Cyclosilicate (SZC) Highlights & Side Effects. Trial Name: NCT04847232 — Phase 3
Sodium Zirconium Cyclosilicate (SZC) (Electrolyte Modifying Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04847232 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other scientific papers that look at Sodium Zirconium Cyclosilicate (SZC)?

"SZC was first researched in 2019. There have been 13 completed studies on the medication to date, with 8 clinical trials still active. Some of these ongoing research projects are based in Las Vegas."

Answered by AI

Does this research allow participants who are middle-aged?

"According to the eligibility requirements for this trial, patients must be between 18-130 years old. There are 2 studies currently being conducted for individuals under 18 and 26 for people 65+."

Answered by AI

Does this kind of experiment with drugs happen very often?

"There have been a total of 8 clinical trials for Sodium Zirconium Cyclosilicate (SZC), the first of which was in 2019. So far, 27 countries and 136 cities have participated in these studies. The sponsor for the first study was AstraZeneca and it reached Phase 3 approval after involving 90 patients. As of now, 13 out of the 8 original studies have completed."

Answered by AI

Does this clinical trial have a high rate of occurrence in state?

"At present, there are 58 sites running this clinical trial. They are located in cities such as Las Vegas, San Antonio and Shenandoah among others. If you choose to participate in the trial, it may be helpful to select a clinic that is nearest to your location to minimize travel requirements."

Answered by AI

Has the FDA cleared Sodium Zirconium Cyclosilicate (SZC) for human use?

"There is some data supporting the efficacy of Sodium Zirconium Cyclosilicate (SZC), and it has undergone multiple rounds of testing for safety, so our team at Power gives it a safety rating of 3."

Answered by AI

Are there any available openings for participants in this research?

"That is correct. The clinical trial, which was originally posted on April 30th 2021 and updated September 29th 2022, is actively recruiting 2300 participants from 58 different locations."

Answered by AI

Could I possibly qualify to be a part of this clinical trial?

"This medical trial needs 2300 individuals, who have hyperkalemia and are between 18-130 years old. Furthermore, these patients must also meet the following qualifications: Be able to provide signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol, Agree to provide 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 enrolled in Japan, a written informed consent should be obtained from both the participant and his or her legally acceptable representative"

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I just finished a study in Redlands, Ca... It was very interesting... so thought I would try something closer to home...Victorville, Ca.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
2021. "Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04847232.
~689 spots leftby Apr 2025
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