Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2) for Hyperkalemia

Phase-Based Estimates
2
Effectiveness
3
Safety
Research Site, Chongqing, China
Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2) - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Hyperkalemia

Study Summary

A Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Doses of Sodium Zirconium Cyclosilicate (SZC) for Correction of Hyperkalaemia and Effectiveness of Same Dose to Maintain Normokalaemia.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2) will improve 2 primary outcomes, 19 secondary outcomes, and 1 other outcome in patients with Hyperkalemia. Measurement will happen over the course of At baseline and during the up to 3 days CP.

Week 3
Maintenance Phase Secondary objective: To evaluate the effect of SZC vs placebo on plasma electrolytes (including bicarbonate) and spot urinary pH and electrolytes
Maintenance Phase Secondary objective: To evaluate the effect of SZC vs placebo on serum aldosterone (S-Aldo) at the end of the MP
Week 4
Maintenance Phase Secondary Objective: To evaluate the effect of SZC vs placebo on mean change from baseline S-K+ during the MP
Maintenance Phase Secondary Objective: To evaluate the effect of SZC vs placebo on the change in S-K+ levels over the MP
Day 3
Correction Phase Secondary objective To evaluate SZC DLs on time to reduction of S-K+ levels during the CP
Correction Phase Secondary objective: To evaluate SZC DLs on the reduction of S-K+ levels during the CP
Correction Phase secondary objective: To evaluate SZC DLs on achieving normokalaemia within the first 72h
Correction phase (CP) primary objective: To evaluate SZC efficacy of different dose levels (DLs) on achieving normokalaemia during the CP
Day 3
Correction phase secondary objective: To evaluate the acceptability and palatability of SZC
Week 22
Long Term Maintenance Phase Secondary objective: To evaluate the acceptability and palatability of SZC
Week 4
Maintenance Phase Secondary objective: To evaluate the acceptability and palatability of SZC
Week 22
Long Term Maintenance Phase Secondary Objective: To evaluate long-term maintenance of normokalaemia during treatment with SZC
Long Term Maintenance Phase Secondary objective: To evaluate long-term maintenance of normokalaemia during treatment with SZC
Long Term Maintenance Phase secondary objective: To evaluate long-term maintenance of normokalaemia during treatment with SZC
Week 4
28-day maintenance phase (MP) primary objective: To compare the effect of SZC vs placebo on maintaining normokalaemia during the MP
Maintenance Phase Secondary Objective: To evaluate the effect of SZC vs placebo on time to increase in S-K+ during the MP
Maintenance Phase Secondary objective. To evaluate the effect of SZC vs placebo on the proportion of participants with normokalaemia per visit over the MP
Maintenance Phase Secondary objective: To evaluate the effect of SZC vs placebo on proportion of visits of normokalaemia during the MP
Maintenance Phase Secondary objective: To evaluate the effect of SZC vs placebo on the proportion of participants experiencing hypo- or hyperkalaemia during the MP
Maintenance Phase secondary objective: To evaluate the effect of SZC vs placebo on time from randomization to relapse of hyperkalaemia
Day 3
Correction Phase Secondary objective To evaluate SZC DLs on time to achieving normokalaemia during the CP
Week 27
Safety objective: To evaluate the safety and tolerability of SZC in the 3 phases (CP, MP and LTMP), and of SZC in relation to placebo in the MP

Trial Safety

Trial Design

2 Treatment Groups

Placebo Arm
Active Arm ( Sodium Zirconium Cyclosilicate SZC)
Placebo group

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2) 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.

Active Arm ( Sodium Zirconium Cyclosilicate SZC)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 that should be mixed with water to the appropriate concentration. Packaging and labelling: Study treatment will be provided in sachets packed in cartons or sprinkle capsules in high density polyethylene (HDPE) 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.
Placebo Arm
Drug
Silicified microcrystalline cellulose (placebo) Dosage formulation: Placebo to match 2.5 g sachets Route of administration: Oral Dosing Instructions: Placebo should be prepared in the same manner as the active drug product Packaging and labelling: Placebo is packaged in sachets packed in cartons or sprinkle capsules in HDPE bottles in accordance with the active drug product. Microcrystalline cellulose (placebo) Dosage formulation: Placebo to match 0.25 g sprinkle capsules Route of administration: Oral Dosing Instructions: Placebo should be prepared in the same manner as the active drug product Packaging and labelling: Placebo is packaged in sachets packed in cartons or sprinkle capsules in HDPE bottles in accordance with the active drug product.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at week 1 and week 22 of ltmp
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at week 1 and week 22 of ltmp for reporting.

Closest Location

Research Site - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Hyperkalemia. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants must meet 1 of the following criteria for hyperkalaemia: (a) For participants ≥2 years of age, mean i STAT K+ level >5.0 mmol/L at Screening. Two consecutive i STAT K+ values, measured 60 (±15) minutes apart, both >5.0 mmol/L and measured within 1 day before the first dose of SZC on CP Study Day 1. (b) For participants <2 years of age, i STAT K+ level >6.0 mmol/L at Screening, measured within 1 day before the first dose of SZC on CP Study Day 1. Note that if Day 1 is the same as the Screening day, the 60 (±15) minute K+ value is the same as the Day 1 time 0 K+ value. However, if Day 1 is not the same day as Screening, then the participant will actually have 3 i STAT-K+ values measured before starting treatment in the CP and the third value which is taken on Day 1 time 0 must also be hyperkalaemic.
Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening: (a) For participants aged 0 to ≤3 days after birth: <450 ms (b) For participants aged >3 days to <12 years: <440 ms (c) For participants ≥12 to <18 years: <450 ms (male), <460 ms (female) All QTcB values outside the reference values specified in the protocol should be manually re-measured and re-calculated, and if there is a difference in measurement between the automatic and manual ECG, the manual measurement should always be considered correct.
You are able to have repeated blood draws or effective venous catheterisation. show original
You are sexually active and you are using 2 forms of medically acceptable contraception with at least 1 being a barrier method. show original
Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate).
You are female or male from birth to <18 years of age.\n show original
Participants (including those receiving a stable peritoneal dialysis regimen) requiring long term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort ≥2 years, and participants requiring either short- or long-term treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort <2 years.

Patient Q&A Section

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

What are the common side effects of sodium zirconium cyclosilicate (szc) dose level 3 (dl3)?

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Results from a recent paper provides clinical evidence that szc overdose and side effects can be minimized by the prudent use of szc. A prospective multicenter study evaluating the safety and efficacy of high dose szc is warranted.

Unverified Answer

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

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Hyperkalemia is seen more frequently in patients with chronic kidney disease than in the general population, although these percentages are fairly similar. The overall incidence of hyperkalemia in the general population of adults is low, at an estimated 1.1% in the US population.

Unverified Answer

Can hyperkalemia be cured?

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Hyperkalemia is common in hospitalized patients and is usually not treated. Rapid and aggressive treatment of hyperkalemia can be lifesaving. Hyperkalemia can be effectively treated in asymptomatic hospitalized patients. Hyperkalemia is not a curable disease, and many patients are dependent on daily potassium replacement for the rest of their lives.

Unverified Answer

What are common treatments for hyperkalemia?

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Hyperkalemia is a frequent condition in hospitalized patients. In many cases the treatment is only for the acute hyperkalemia. Many patients need to be reevaluated in order to treat the cause of hyperkalemia.

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What are the signs of hyperkalemia?

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Most children who have a diagnosis of hyperkalemia have no symptoms in children of all ages. In contrast, symptoms in children ≥ 6 years of age include ataxia, arrhythmias, ventricular fibrillation, and seizures. Hyperkalemia of ≥ 5.1 mmol/L has an estimated prevalence of 3-5% in this age group. A serum potassium of > 5 mmol/l is associated with a low-mortality in patients with heart disease.

Unverified Answer

What is hyperkalemia?

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Hyperkalemia can result in serious metabolic derangements that can lead to cardiac arrhythmias or even death. High levels of potassium in the blood can be measured on a variety of blood testing techniques; however, the most sensitive method for detecting hyperkalemia is by measurement of sodium and potassium concentrations, a test called an electrolyte panel.\n

Unverified Answer

What causes hyperkalemia?

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Factors contributing directly to hyperkalemia include an increased level of potassium in the systemic circulation, increased net potassium excretion from the body, and decreased plasma volume. However, it is rarely caused directly by medications because hyperkalemia is less likely to occur at doses that are used therapeutically than by high doses given therapeutically. Hyperkalemia is most often the result of other diseases and medications. In most cases, the primary cause of hyperkalemia is chronic kidney failure and use of certain medications. Drugs affecting gastrointestinal absorption may increase the risk of hyperkalemia. The primary treatment for hyperkalemia lies in treating the underlying causes of the hyperkalemia.

Unverified Answer

Have there been any new discoveries for treating hyperkalemia?

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The advancement of medical research, treatment algorithms, and clinical practice is the best source for treating hyperkalemia. In a recent study, findings indicate that there are a few treatment algorithms that may reduce the risk of developing hyperkalemia-related cardiac conditions, including heart failure.

Unverified Answer

Is sodium zirconium cyclosilicate (szc) dose level 3 (dl3) typically used in combination with any other treatments?

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DL3 was most often used with a platinum agent and a gemcitabine or a capecitabine, with a median DL3 of 80 mg. Given that DL3 is the most well-established DL, it is most appropriate to continue using this amount of szc when assessing tolerability parameters.

Unverified Answer

What is the primary cause of hyperkalemia?

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Cardiac arrhythmias seem to be accountable for 50% of cases and hyperkalemia of a non-cardiac nature for 5.8% of the cases. Since there is no significant difference in other risk factors between those with cardiac arrhythmias and those with non-cardiac hyperkalemia, electrocardiographic changes do not seem to play a major role in the etiology of hyperkalemia. A complete elimination of all causes of hyperkalemia may not be achievable.

Unverified Answer

What is the average age someone gets hyperkalemia?

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Hyperkalemia is common after pediatric and older adult hospitalizations. Hyperkalemia can cause significant medical problems, with potentially fatal and debilitating results. Hyperkalemia is often (75%) associated with certain organ failure, especially cardiovascular failure. Early identification and treatment of these hyperkalemia-associated conditions may help prevent and correct the complications of hyperkalemia.

Unverified Answer

Is sodium zirconium cyclosilicate (szc) dose level 3 (dl3) safe for people?

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Szc dl3 is well-tolerated and safe for people with hyperkalemia as assessed by electrocardiogram (ECG). There is the potential for long-term cardiovascular disease if there is high blood pressure in people with kidney disease.

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