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Ion-exchange Resin

SZC for Hyperkalemia (PEDZ-K Trial)

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

Must not have

Participants with suspected conditions predisposing them to intestinal ischaemia

Participants with a family history of long QT syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at each scheduled visit

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am under 18 years old.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I might have a condition that reduces blood flow to my intestines.

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My family has a history of long QT syndrome.

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I have had temporary high potassium levels due to treatment.

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I am pregnant, breastfeeding, or planning to become pregnant.

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I haven't used any unapproved drugs or devices in the last 30 days.

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I have a severe stomach or gut condition or had major surgery on it.

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I am currently on dialysis.

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I have a heart rhythm problem that needs immediate treatment.

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I have had a blockage in my intestines before.

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I have been treated with SZC before.

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My baby was born before 37 weeks or weighed less than 2500g at birth.

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I have high potassium levels due to another health condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 16Eligibility criteria met