What is the mechanism of action of this treatment?

Oral potassium binders, such as cation exchange resins, are commonly used to treat hyperkalemia by lowering blood potassium levels. These agents work by exchanging sodium or calcium for potassium in the gastrointestinal tract, thereby facilitating the removal of excess potassium from the body. This mechanism is vital for hyperkalemia patients because elevated potassium levels can cause severe cardiac complications, including arrhythmias and cardiac arrest. Effective management of potassium levels through these treatments helps prevent these life-threatening conditions.

What side effects are associated with this type of intervention?

The most common treatments for hyperkalemia using oral potassium binders, such as sodium polystyrene sulfonate (SPS) and calcium polystyrene sulfonate, are associated with several side effects. These include gastrointestinal disturbances like constipation, diarrhea, nausea, and vomiting. There is also a risk of sodium overload with sodium-based resins, which can lead to fluid retention and hypertension. Additionally, calcium-based resins may cause hypercalcemia. Rare but serious side effects include intestinal necrosis and colonic perforation, particularly in patients with underlying bowel disease or those who are post-operative.

What prior FDA approvals exist?

The FDA has approved several oral potassium binders for the treatment of hyperkalemia, which work by exchanging sodium or calcium for potassium in the gastrointestinal tract. Notable examples include sodium polystyrene sulfonate (Kayexalate) and patiromer (Veltassa). These medications help to lower blood potassium levels by binding potassium in the gut and facilitating its excretion. Another recent approval is sodium zirconium cyclosilicate (Lokelma), which also acts as a cation exchange resin to treat hyperkalemia effectively.

What other types of research exist?

Promising novel alternatives to oral potassium binders for hyperkalemia treatment include patiromer and sodium zirconium cyclosilicate. These agents work by binding potassium in the gastrointestinal tract, similar to traditional cation exchange resins, but they have shown improved efficacy and safety profiles in clinical trials. Additionally, ongoing research into gene therapy and novel small molecules targeting renal potassium excretion may offer future therapeutic options.

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Cation Exchange Resin

Potassium Binders for Hyperkalemia (KBindER Trial)

Phase 4

Recruiting

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

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

Must have

Age ≥18 years

Be older than 18 years old

Must not have

Active psychiatric disorder

Pseudohyperkalemia signs and symptoms, such as excessive fist clenching, hemolyzed blood specimen, severe leukocytosis or thrombocytosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up plasma potassium level measured at 2 and 4 hours after study drug was administered

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial is testing different medicines to lower high blood potassium in hospital patients. These medicines work by capturing potassium in the gut and removing it through stool. The goal is to find out which medicine works best for these patients. New medicines are being tested for their ability to manage high blood potassium by enhancing potassium removal through the digestive system.

Who is the study for?

This trial is for adults over 18 with high blood potassium levels (above 5.5 mEq/L) who can consent to participate. It's not for those with recent bowel surgery, blockages, certain blood issues mimicking high potassium, pregnant women, people with active psychiatric disorders or severe allergies to the drugs being tested.

What is being tested?

The study compares three oral medications—Polyethylene Glycol 3350, Sodium Polystyrene Sulfonate [SPS], and Patiromer—to see which is best at lowering dangerously high potassium in hospital patients.

What are the potential side effects?

Possible side effects of these potassium binders include digestive discomfort like nausea or constipation, electrolyte imbalances that could affect heart rhythm and muscle function, and rarely intestinal damage.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

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

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I am currently experiencing a psychiatric disorder.

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My high potassium levels are due to factors like tight fist clenching or a bad blood sample.

Select...

I am not taking sorbitol with sodium polystyrene sulfonate.

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I have a blockage in my intestines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 2 and 4 hours after study drug was administered

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 2 and 4 hours after study drug was administered

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 2 and 4 hours after study drug was administered for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in blood potassium level

Secondary study objectives

Change in calcium, phosphorus and magnesium

Dialysis yes/no within 8 hours

Length of ER or hospital stay

+1 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Sodium zirconium cyclosilicate (Lokelma)Experimental Treatment1 Intervention

Participants will be randomized to one of four study arms. They will receive one dose of the study drug. The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).

Group II: Sodium polystyrene sulfonate (Kayexalate)Experimental Treatment1 Intervention

Group III: Polyethylene glycol 3350 (MiraLax)Experimental Treatment1 Intervention

Participants will be randomized to one of four study arms. They will receive one dose of the study drug. One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.

Group IV: Patiromer (Veltassa)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Polyethylene glycol

FDA approved

Patiromer

FDA approved

Sodium zirconium cyclosilicate

FDA approved

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Oral potassium binders, such as cation exchange resins, are commonly used to treat hyperkalemia by lowering blood potassium levels. These agents work by exchanging sodium or calcium for potassium in the gastrointestinal tract, thereby facilitating the removal of excess potassium from the body. This mechanism is vital for hyperkalemia patients because elevated potassium levels can cause severe cardiac complications, including arrhythmias and cardiac arrest. Effective management of potassium levels through these treatments helps prevent these life-threatening conditions.