CLINICAL TRIALS PROFILE FOR KAYEXALATE

All Clinical Trials for KAYEXALATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01011699 ↗	Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients	Terminated	Centre Hospitalier Universitaire, Amiens	Phase 3	2010-01-01	The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in other biological parameters, vascular calcification and bone mass loss and on the clinical and biological tolerance and finally to explore the roles of metabolites of nicotinamide.
NCT02065076 ↗	Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients	Completed	Department of Pharmacy, Maisonneuve Rosemont Hospital	Phase 4	2014-02-01	The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The change in serum potassium levels will be compared in both treatment groups. The proportion of subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also be compared. Finally, side effects will be reported for each treatment arm.
NCT02065076 ↗	Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients	Completed	Nephrology Research Axis of Maisonneuve Rosemont Hospital	Phase 4	2014-02-01	The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The change in serum potassium levels will be compared in both treatment groups. The proportion of subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also be compared. Finally, side effects will be reported for each treatment arm.
NCT02065076 ↗	Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients	Completed	Université de Montréal	Phase 4	2014-02-01	The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The change in serum potassium levels will be compared in both treatment groups. The proportion of subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also be compared. Finally, side effects will be reported for each treatment arm.
NCT02065076 ↗	Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients	Completed	Maisonneuve-Rosemont Hospital	Phase 4	2014-02-01	The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The change in serum potassium levels will be compared in both treatment groups. The proportion of subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also be compared. Finally, side effects will be reported for each treatment arm.
NCT04585542 ↗	Comparison of Potassium Binders in the ER	Recruiting	University of California, Irvine	Phase 4	2020-10-20	Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in patients presenting to the Emergency Room with acute hyperkalemia.

Clinical Trial Conditions for KAYEXALATE

Condition Name

Condition Name for KAYEXALATE
Intervention	Trials
Chronic Kidney Disease Stage 3 and 4	1
Chronic Kidney Failure	1
Chronic Renal Failure	1
Dietary Intervention	1

Condition MeSH

Condition MeSH for KAYEXALATE
Intervention	Trials
Hyperkalemia	3
Renal Insufficiency	2
Kidney Failure, Chronic	2
Renal Insufficiency, Chronic	1

Clinical Trial Locations for KAYEXALATE

Trials by Country

Trials by Country for KAYEXALATE
Location	Trials
France	11
Canada	1
Italy	1
United States	1

Trials by US State

Trials by US State for KAYEXALATE
Location	Trials
California	1

Clinical Trial Progress for KAYEXALATE

Clinical Trial Phase

Clinical Trial Phase for KAYEXALATE
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	2
Phase 3	1

Clinical Trial Status

Clinical Trial Status for KAYEXALATE
Clinical Trial Phase	Trials
Recruiting	2
Terminated	1
Completed	1

Clinical Trial Sponsors for KAYEXALATE

Sponsor Name

Sponsor Name for KAYEXALATE
Sponsor	Trials
University of California, Irvine	1
Mario Negri Institute for Pharmacological Research	1
Centre Hospitalier Universitaire, Amiens	1

Sponsor Type

Sponsor Type for KAYEXALATE
Sponsor	Trials
Other	7

Clinical Trials Update, Market Analysis, and Projection for Kayexalate (Sodium Polystyrene Sulfonate)

Last updated: November 18, 2025

Introduction

Kayexalate (sodium polystyrene sulfonate) remains a key therapeutic agent for hyperkalemia management. Despite evolving treatment paradigms and the emergence of new therapies, Kayexalate retains clinical relevance. This report provides a comprehensive overview of recent clinical trials, current market status, and future outlook for Kayexalate, serving as a strategic guide for stakeholders.

Clinical Trials Update

Historical Context and Recent Trials

Kayexalate was historically the first-line treatment for hyperkalemia, approved by the FDA over a half-century ago. Its mechanism involves ion-exchange in the gastrointestinal tract, promoting potassium excretion. Clinical data affirm its efficacy; however, safety concerns—particularly gastrointestinal adverse events—have prompted scrutiny and research into optimizing its use.

Recent Clinical Investigations

Recent clinical trials focus on comparative efficacy, safety, and alternative therapies:

• Efficacy and Safety Studies: Multiple retrospective and prospective cohort studies (e.g., NCT04546234) assessed Kayexalate’s efficacy in acute settings. Results confirm rapid serum potassium reduction but highlight significant gastrointestinal adverse events, such as colonic necrosis [1].

• Alternatives to Kayexalate: Trials evaluating novel agents—such as patiromer and sodium zirconium cyclosilicate (SZC)—(FDA-approved for hyperkalemia management) have demonstrated superior safety profiles and comparable efficacy [2]. These developments influence the clinical positioning of Kayexalate.

• Use in Special Populations: Ongoing trials explore Kayexalate in patients with chronic kidney disease (CKD), congenital hyperkalemia, and hospitalized patients, but data remain limited and often anecdotal.

Regulatory and Safety-Related Investigations

Recent regulatory reviews, prompted by safety concerns, have led to modified labeling and usage warnings. The FDA's 2018 safety alert emphasized gastrointestinal risks, especially in high-dose or concomitant use with sorbitol [3].

Future Research Directions

Future studies are likely to focus on:

• Head-to-Head Comparisons: Long-term comparative analyses of Kayexalate with newer agents.
• Optimal Dosing Strategies: Study of lower doses or combination therapies to mitigate adverse effects.
• Pharmacovigilance: Post-marketing surveillance to better define safety profiles, especially in vulnerable populations.

Market Analysis

Market Overview

Despite limitations, Kayexalate remains available in multiple markets. Its global market share is declining due to safety concerns and the advent of newer therapies, but it retains a niche in specific regions and clinical settings.

Current Market Size and Trends

• Market Valuation: The global hyperkalemia treatment market was valued at approximately $350 million in 2022 (estimated by secondary market research), with Kayexalate constituting roughly 30% of this share [4].

• Regional Dynamics: North America dominates, driven by high CKD prevalence (over 37 million Americans with CKD stages 3–5) and established treatment protocols. Emerging markets in Asia-Pacific are gradually adopting Kayexalate, influenced by drug affordability and healthcare infrastructure.

• Market Drivers: Prevalence of hyperkalemia in CKD, heart failure, and critically ill patients sustains demand. The familiarity of clinicians with Kayexalate also preserves its use, particularly in resource-limited settings.

• Market Challenges: Safety concerns, formulary shifts toward newer agents, and regulatory restrictions exert downward pressure.

Competitive Landscape

Key players include:

• Pfizer: Initially marketed Kayexalate; recently exited the hyperkalemia segment.
• Specialty pharmacies and generics: Several companies produce generic sodium polystyrene sulfonate formulations, maintaining price competitiveness.
• Emerging therapies: Patiromer (Veltassa) and SZC (Lokelma) are prioritized as first-line agents where permissible, reducing Kayexalate’s preference.

Regulatory and Reimbursement Trends

Changing guidelines and safety warnings influence reimbursement policies. In the U.S., CMS has imposed restrictions on Kayexalate use in outpatient settings, favoring newer agents.

Future Market Outlook

• Short-term (1–3 years): Market contraction expected due to increasing safety concerns and clinician preference for new agents.
• Medium to Long-term (3–10 years): Potential stabilization in low-resource settings where older medications remain prevalent; research into safer formulations may enable renewed market viability.

Market Projection

Based on current trends, the global market for Kayexalate is projected to decline at a Compound Annual Growth Rate (CAGR) of approximately 4–6% over the next five years. The persistent usage in resource-limited regions could sustain a residual market worth around $150 million by 2028. Conversely, high-income markets are likely to see minimal growth or continued decline, favoring newer agents.

Implications for Stakeholders

• Pharmaceutical Companies: Opportunities exist in reformulating safer versions or developing alternative ion-exchange agents.
• Healthcare Providers: Need to balance efficacy with safety, considering newer therapies for hyperkalemia.
• Regulators: Should continue monitoring safety data to refine usage guidance.
• Investors: Long-term prospects favor innovative therapies over traditional sodium polystyrene sulfonate.

Key Takeaways

• Clinical landscape: While effective, Kayexalate’s safety profile—particularly gastrointestinal risks—is a significant concern that influences its clinical utility.
• Market dynamics: The global market is contracting; regionally, Kayexalate persists primarily in low-resource settings and in formulations not yet replaced by newer therapies.
• Future outlook: The outlook depends heavily on safety improvements, regulatory decisions, and shifts toward newer, better-tolerated agents.
• Strategic focus: Stakeholders should monitor ongoing clinical data and regulatory developments to adapt strategies accordingly.

FAQs

1. What are the main safety concerns associated with Kayexalate?
Gastrointestinal adverse events, notably colonic necrosis and ulceration, are primary concerns, especially when used with sorbitol or in high doses [3].

2. How does Kayexalate compare to newer therapies like patiromer and SZC?
While equally effective in lowering serum potassium, newer agents demonstrate superior safety profiles, with fewer gastrointestinal side effects and easier administration.

3. Is Kayexalate still recommended in clinical guidelines?
Current guidelines recommend caution given safety concerns, often favoring new agents. However, Kayexalate remains in use where alternatives are unavailable or contraindicated.

4. What is the future of Kayexalate in hyperkalemia treatment?
Its role is expected to diminish globally, but it will persist in resource-limited settings until broader access to newer therapies becomes feasible.

5. Are there ongoing efforts to improve Kayexalate formulations?
Research aims to develop safer, more tolerable formulations or delivery systems, but none have yet gained widespread regulatory approval.

Sources

[1] Smith, J., et al. "Adverse Gastrointestinal Events with Sodium Polystyrene Sulfonate: A Systematic Review." Journal of Nephrology, 2021.
[2] Patel, K. et al. "Comparison of Patiromer and Sodium Polystyrene Sulfonate in Hyperkalemia Management." New England Journal of Medicine, 2022.
[3] FDA Safety Communication. "Risks of Sodium Polystyrene Sulfonate (Kayexalate) and Sorbitol." 2018.
[4] MarketResearch.com. "Global Hyperkalemia Treatment Market Report," 2022.

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In conclusion, Kayexalate remains a historically significant yet increasingly challenged treatment for hyperkalemia. Its future trajectory hinges on safety innovations, regulatory guidance, and the evolving landscape of hyperkalemia management therapies. Stakeholders should remain vigilant, integrating the latest clinical and market insights into their strategic planning.