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This trial will study whether SZC can help improve cardiovascular outcomes for those with hyperkalemia on hemodialysis.
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You have already been chosen at random to participate in this study before.Your QTcF heart measurement is longer than 550 milliseconds.You have experienced a prolonged QT interval due to taking other medications, and had to stop taking those medications because of this.You were born with a heart condition that affects your heart's electrical activity.You have atrial fibrillation that needs immediate attention.You have taken certain medications for managing potassium levels within 7 days before the screening, or you are expected to take these medications regularly during the study. If you need emergency treatment for high potassium levels during the screening period, you will not be eligible for the study.You have had a severe allergic reaction to SZC or its ingredients before.You have a planned date for getting a kidney from a living donor.You have experienced a specific type of fast heart rhythm for more than 30 seconds that needs to be checked by a doctor.You are currently undergoing hemodialysis or hemodiafiltration at least three times a week for at least four months.You need to have a specific type of access for hemodialysis that will stay in place throughout the study.Your blood potassium levels are consistently high before starting dialysis.Women who could become pregnant need to have a negative pregnancy test.The blood sample taken for testing appears to have broken apart and may not give accurate results. The testing may need to be done again at a later time.
- Group 1: Placebo
- Group 2: Sodium Zirconium Cyclosilicate
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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+."
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."
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."
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."
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."
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"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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