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Ion-exchange Resin

SZC for Hyperkalemia (PEDZ-K Trial)

Q: Are participants currently being recruited for this research?

That is correct. The website clinicaltrials.gov has the most recent information on this trial, which was originally posted on April 2nd, 2019 and updated as recently as October 21st, 2020. They are looking for 90 people to participate across 5 different locations.

Q: What are the investigators hoping to understand by conducting this research?

The goal of this study is to compare the effect of SZC vs placebo on maintaining normokalaemia during the maintenance phase (MP). Secondary outcomes include assess the acceptability and palatability of SZC, evaluate change in serum electrolytes (including bicarbonate), spot urinary pH and urinary electrolytes levels in children treated with SZC during the MP, and time from randomization to relapse of hyperkalaemia in each treatment group.

Q: Are there different locations in this city where people can participate in this trial?

Presently, this clinical trial is taking place in five locations. These are situated in Baltimore, Birmingham and Morgantown as well as two other undisclosed sites. If you are considering participating it might be beneficial to select the site nearest to your location to cut down on travel.

Q: What makes this clinical trial unique compared to others?

There are 8 active global clinical trials for Sodium Zirconium Cyclosilicate (SZC), with the earliest one having taken place in 2019. To date, 90 patients have participated and 13 trials have completed their Phase 3 drug approval stage.

Q: Are there any other examples where SZC has been used over a 28 day period?

The first study on the effects of Sodium Zirconium Cyclosilicate (SZC) during a 28 day maintenance phase was conducted in 2019. So far, there have been 13 completed trials and 8 studies are still recruiting patients. Many of these active studies are located in Baltimore, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>.

Q: Does this research include people over the age of 45?

The age restriction for this clinical trial is between 0 and 18 years old.

Q: How many people total are eligible for this clinical trial?

That is correct. The clinicaltrials.gov website currently lists this study as actively recruiting patients. This research was originally posted on April 2nd, 2019 and has since been updated October 21st, 2022. There are 5 different enrolling locations for a total of 90 participants needed.

Q: Which types of patients does this research require?

To be eligible for this trial, patients must: Be between the ages of 0 and 18 Have hyperkalaemia Meet the following criteria for hyperkalaemia: For participants aged ≥ 2 years, Local Laboratory S-K+ level > 5.0 mmol/L and for participants aged 0 to &#x3C; 2 years, Local Laboratory S-K+ level >6.0 mmol/L at Screening, measured 3 to 14 days prior to first dose of study medication on CP Study Day 1. This should also be confirmed prior to dosing on Day 1.Using digital ECG, QT interval

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female or male from birth to < 18 years of age

Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at each scheduled visit

Awards & highlights

PEDZ-K Trial Summary

This trial will test the efficacy, safety, and tolerability of sodium zirconium cyclosilicate in children up to 18 years of age with hyperkalaemia.

Who is the study for?

This trial is for children under 18 with high blood potassium (hyperkalemia) who need long-term treatment. They must be able to have regular blood tests, not have severe gut issues or major surgeries, and can't be on certain medications or dialysis. Girls who can have babies must use two birth control methods.Check my eligibility

What is being tested?

The study tests different doses of Sodium Zirconium Cyclosilicate (SZC) in kids with hyperkalemia. It has three phases: correction, maintenance, and long-term maintenance where the dose may change to keep potassium levels normal.See study design

What are the potential side effects?

Possible side effects of SZC include stomach pain, nausea, swelling in limbs due to fluid retention, low magnesium levels which might cause muscle weakness or cramps, and changes in heart rhythm.

PEDZ-K Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 18 years old.

Select...

My heart's electrical activity, measured by an ECG, is within the normal range.

Select...

I need treatment for high potassium levels and I am older than 2 years.

Select...

I am not pregnant and use two forms of birth control, including a barrier method.

PEDZ-K Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at each scheduled visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at each scheduled visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and at each scheduled visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

28-day Maintenance Phase (MP) primary objective: To evaluate the ability to maintain normokalaemia during the MP when continuing SZC treatment in children achieving normokalaemia

Correction phase (CP) primary objective: To evaluate the ability to achieve normokalaemia during the CP when initiating treatment with SZC of different dose levels in children with hyperkalaemia

Secondary outcome measures

All phases secondary objective: To evaluate the change in S-K+ in children treated with SZC

Long-term MP (LTMP) secondary objectives: To evaluate the ability of maintaining normokalaemia in children treated with SZC during the LTMP

MP Secondary objective: To evaluate change in serum electrolytes (including bicarbonate), spot urinary pH and urinary electrolytes levels in children treated with SZC during the MP

+1 more

Other outcome measures

Safety objective: To evaluate the safety and tolerability of SZC in the 3 phases (CP, MP and LTMP)

Tertiary/Exploratory objective: To evaluate the acceptability and palatability of SZC through the study

PEDZ-K Trial Design

1Treatment groups

Experimental Treatment

Group I: Active Arm ( Sodium Zirconium Cyclosilicate SZC)Experimental Treatment5 Interventions

Dosage formulation: 5 g sachets 2.5 g sachets 0.25 g sprinkle capsules 0.125 g sprinkle capsules (can be manufactured to support participants <2 years of age) Route of administration: Oral Dosing instructions: SZC is provided as a powder. At the time of dosing SZC is mixed with a quantity of water or sprinkled onto semi-solid food (eg, milk, baby food, yogurt, or ice cream) within an hour of drug administration. Packaging and labelling: Study treatment will be provided in sachets packed in cartons or sprinkle capsules in high density polyethylene bottles, as appropriate for the dose. Each carton of sachets, individual sachets, and bottle of capsules will be labelled in accordance with Good Manufacturing Practice Annex 13 and per country regulatory requirement. Participant-specific dosing cards (diary) will be provided.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,265 Previous Clinical Trials

288,605,142 Total Patients Enrolled

32 Trials studying Hyperkalemia

72,674 Patients Enrolled for Hyperkalemia

Media Library

Sodium Zirconium Cyclosilicate (SZC) (Ion-exchange Resin) Clinical Trial Eligibility Overview. Trial Name: NCT03813407 — Phase 3

Hyperkalemia Research Study Groups: Active Arm ( Sodium Zirconium Cyclosilicate SZC)

Hyperkalemia Clinical Trial 2023: Sodium Zirconium Cyclosilicate (SZC) Highlights & Side Effects. Trial Name: NCT03813407 — Phase 3

Sodium Zirconium Cyclosilicate (SZC) (Ion-exchange Resin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03813407 — Phase 3

Frequently Asked Questions

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

Are participants currently being recruited for this research?

"That is correct. The website clinicaltrials.gov has the most recent information on this trial, which was originally posted on April 2nd, 2019 and updated as recently as October 21st, 2020. They are looking for 90 people to participate across 5 different locations."

Answered by AI

What are the investigators hoping to understand by conducting this research?

"The goal of this study is to compare the effect of SZC vs placebo on maintaining normokalaemia during the maintenance phase (MP). Secondary outcomes include assess the acceptability and palatability of SZC, evaluate change in serum electrolytes (including bicarbonate), spot urinary pH and urinary electrolytes levels in children treated with SZC during the MP, and time from randomization to relapse of hyperkalaemia in each treatment group."

Answered by AI

Are there different locations in this city where people can participate in this trial?

"Presently, this clinical trial is taking place in five locations. These are situated in Baltimore, Birmingham and Morgantown as well as two other undisclosed sites. If you are considering participating it might be beneficial to select the site nearest to your location to cut down on travel."

Answered by AI

What makes this clinical trial unique compared to others?

"There are 8 active global clinical trials for Sodium Zirconium Cyclosilicate (SZC), with the earliest one having taken place in 2019. To date, 90 patients have participated and 13 trials have completed their Phase 3 drug approval stage."

Answered by AI

Are there any other examples where SZC has been used over a 28 day period?

"The first study on the effects of Sodium Zirconium Cyclosilicate (SZC) during a 28 day maintenance phase was conducted in 2019. So far, there have been 13 completed trials and 8 studies are still recruiting patients. Many of these active studies are located in Baltimore, Maryland."

Answered by AI

Does this research include people over the age of 45?

"The age restriction for this clinical trial is between 0 and 18 years old."

Answered by AI

How many people total are eligible for this clinical trial?

"That is correct. The clinicaltrials.gov website currently lists this study as actively recruiting patients. This research was originally posted on April 2nd, 2019 and has since been updated October 21st, 2022. There are 5 different enrolling locations for a total of 90 participants needed."

Answered by AI

Which types of patients does this research require?

"To be eligible for this trial, patients must: Be between the ages of 0 and 18 Have hyperkalaemia Meet the following criteria for hyperkalaemia: For participants aged ≥ 2 years, Local Laboratory S-K+ level > 5.0 mmol/L and for participants aged 0 to < 2 years, Local Laboratory S-K+ level >6.0 mmol/L at Screening, measured 3 to 14 days prior to first dose of study medication on CP Study Day 1. This should also be confirmed prior to dosing on Day 1.Using digital ECG, QT interval"

Answered by AI

What sort of health risks have been associated with taking SZC during the 28 day maintenance phase?

"This clinical trial is in Phase 3, which means that there is some data supporting efficacy and multiple rounds of data supporting safety. Our team at Power estimates the safety of Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase to be a 3 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia

2019. "An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03813407.

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