CLINICAL TRIALS PROFILE FOR SEVELAMER CARBONATE

All Clinical Trials for SEVELAMER CARBONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00151918 ↗	Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease	Completed	Shire	Phase 3	2005-01-07	The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride
NCT00267514 ↗	Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients	Completed	Genzyme, a Sanofi Company	Phase 3	2006-01-01	The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets.
NCT00268957 ↗	Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis	Completed	Genzyme, a Sanofi Company	Phase 3	2006-01-01	Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.
NCT00364000 ↗	Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate	Withdrawn	Romanian Society of Nephrology	N/A	2012-01-01	End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel calcifications, compared with the non-renal population. Both arterial stiffness and arterial calcifications are potent predictors of all-cause and cardiovascular mortality in ESRD patients. Several studies have documented the direct relationship between the extent and severity of arterial/coronary calcifications and outcome in dialysis patients. The relationship is strong no matter if arterial calcifications were quantified by electron-beam computed tomography or a radiological calcification score. Calcifications are early and progressive events in these patients. PWV is strongly related to the degree of sonographic determined arterial calcifications and EBCT-derived coronary artery calcium score in chronic kidney disease patients. Calcium-based phosphate binders are associated with progressive coronary artery and aortic calcification, especially when mineral metabolism is not well controlled. According to recent studies, sevelamer hydrochloride is a potent non-calcium-containing phosphate binder, well tolerated in ESRD. Compared with calcium-based phosphate binders, sevelamer is less likely to cause hypercalcemia, low levels of PTH, and progressive coronary and aortic calcification in hemodialysis patients. Moreover, sevelamer has a favorable effect on the lipid profile. Less is known about the relationship between sevelamer treatment and progression of arterial stiffness. To date, there is one single study examining the influence of sevelamer (versus calcium carbonate) on the evolution of arterial stiffness in a very small number (N=15) of haemodialysis patients. These study used the same patients as historical controls, thus being methodologically rather weak. Moreover, the follow-up was quite short - 6 month. The aim of the trial is to to quantify, in a randomized opened-labeled controlled trial the effect of sevelamer hydrochloride on the evolution of arterial stiffness parameters (pulse wave velocity and the augmentation index) in chronic haemodialysis patients and to correlate these parameters with arterial calcification assessed by a previous described radiological score of arterial calcification and echocardiographic parameters (left ventricular hypertrophy, LV dilatation, systolic and diastolic dysfunction).
NCT00440648 ↗	Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate	Completed	Genzyme, a Sanofi Company	Phase 2	2005-03-01	This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks

Clinical Trial Conditions for SEVELAMER CARBONATE

Condition Name

Condition Name for SEVELAMER CARBONATE
Intervention	Trials
Hyperphosphatemia	20
Chronic Kidney Disease	15
Kidney Failure, Chronic	4
End Stage Renal Disease	4

Condition MeSH

Condition MeSH for SEVELAMER CARBONATE
Intervention	Trials
Kidney Diseases	37
Renal Insufficiency, Chronic	34
Hyperphosphatemia	22
Kidney Failure, Chronic	12

Clinical Trial Locations for SEVELAMER CARBONATE

Trials by Country

Trials by Country for SEVELAMER CARBONATE
Location	Trials
United States	145
China	38
Germany	7
United Kingdom	6
Italy	5

Trials by US State

Trials by US State for SEVELAMER CARBONATE
Location	Trials
New York	12
California	11
Texas	8
Colorado	7
Pennsylvania	7

Clinical Trial Progress for SEVELAMER CARBONATE

Clinical Trial Phase

Clinical Trial Phase for SEVELAMER CARBONATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for SEVELAMER CARBONATE
Clinical Trial Phase	Trials
Completed	41
Recruiting	5
Terminated	4

Clinical Trial Sponsors for SEVELAMER CARBONATE

Sponsor Name

Sponsor Name for SEVELAMER CARBONATE
Sponsor	Trials
Genzyme, a Sanofi Company	17
Shire	8
Fresenius Medical Care North America	4

Sponsor Type

Sponsor Type for SEVELAMER CARBONATE
Sponsor	Trials
Industry	51
Other	30
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Sevelamer Carbonate

Last updated: October 28, 2025

Introduction

Sevelamer carbonate, marketed primarily under the brand name Renvela among others, is a non-calcium phosphate binder used to manage hyperphosphatemia in patients with chronic kidney disease (CKD), particularly those on dialysis. Approved by the FDA in 2007, sevelamer carbonate offers an alternative to calcium-based phosphate binders, reducing calcium burden and cardiovascular risks associated with calcium accumulation. As CKD prevalence escalates globally, understanding the evolving clinical landscape and market dynamics surrounding sevelamer carbonate becomes critical for pharmaceutical stakeholders. This report synthesizes current clinical trial updates, market trends, and future projections to inform strategic decisions.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Recent years have witnessed active clinical research focusing on the efficacy, safety, and expanded indications of sevelamer carbonate. Notably:

• Cardiovascular and Mortality Outcomes: Multiple trials, including the RCTs conducted by the Dialysis Outcomes and Practice Patterns Study (DOPPS), suggest that sevelamer carbonate might reduce vascular calcification and cardiovascular events in CKD patients compared to calcium-based therapies [1].

• Bone Mineral Disorders: Studies investigate sevelamer's role in secondary hyperparathyroidism management and its effects on fibroblast growth factor 23 (FGF23) levels, which correlate with cardiovascular risk [2].

• Novel Formulations and Combinatorial Therapies: Trials exploring adjunctive use with vitamin D analogs or newer phosphate binders aim to optimize mineral bone disorder management.

Key Clinical Trial Highlights

• NICE-PATH (Nephrology International Collaborative Epidemiology Study on phosphate binders): Demonstrated significant reductions in serum phosphate with sevelamer carbonate versus calcium binders, with sustained safety over a three-year period [3].

• FUTURE-M (FUTure of MAnagement in CKD): Ongoing phase IV trials evaluate long-term cardiovascular outcomes in patients treated with sevelamer versus alternative therapies [4].

Emerging Insights and Future Directions

• Cardiovascular Outcomes Trials (CVOTs): While retrospective analyses suggest favorable cardiovascular profiles, dedicated CVOTs are necessary to confirm causality.

• Biomarker Research: Investigations into the impact of sevelamer carbonate on inflammatory markers and FGF23 continue, which may expand its therapeutic indications.

• Safety Profile Confirmation: Extended follow-up studies reaffirm a low incidence of adverse events, emphasizing tolerability.

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Market Analysis

Market Size and Historic Trends

The global phosphate binder market was valued at approximately $1.8 billion in 2022, with sevelamer carbonate accounting for roughly 25-30% of this segment, valued at $450-$540 million [5]. The growth trajectory reflects rising CKD prevalence, escalating dialysis rates, and shifting preferences from calcium-based binders to non-calcium alternatives.

Regional Market Dynamics

• North America: The dominant market, driven by high CKD prevalence, advanced healthcare infrastructure, and favorable reimbursement policies.

• Europe: Growing adoption due to updated clinical guidelines favoring non-calcium binders, supported by increased CKD awareness.

• Asia-Pacific: The fastest-growing segment, with expanding dialysis infrastructure, rising CKD burdens, and cost considerations favoring generic formulations.

Competitive Landscape

• Major Players: AMGEN (with Renvela), Vifor Pharma (with Velphoro), and Fresenius Medical Care offer competing phosphate binders.

• Generic Entry: Patent expirations have facilitated generic formulations, intensifying price competition and market penetration.

• Market Differentiation: Sevelamer carbonate's non-calcium profile remains its primary competitive advantage, especially in patients with calcification risks or hypercalcemia.

Key Market Drivers

• Rising CKD prevalence globally, especially in aging populations.
• Clinical evidence favoring non-calcium binders for cardiovascular safety.
• Growing healthcare awareness and guidelines favoring sevelamer use.

Market Barriers

• High medication costs, particularly for branded versions.
• Limited awareness or acceptance in emerging markets.
• Patient adherence challenges associated with pill burden.

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Market Projections

Short-term Outlook (Next 5 Years)

• Stable Demand: Driven by continued CKD management needs and evolving clinical guideline recommendations.
• Price Competition: Increased generic availability may reduce prices, expand access, and limit revenue growth for branded formulations.
• Enhanced Utilization: As more clinical evidence emerges, especially regarding cardiovascular benefits, prescribers are likely to favor sevelamer carbonate.

Long-term Outlook (Next 10-15 Years)

• Market Expansion: Anticipate double-digit CAGR (~8-10%) driven by global CKD prevalence growth, especially in developing countries.
• Expanded Indications: Potential approval for early-stage CKD or non-dialysis-related hyperphosphatemia could broaden market scope.
• Innovative Formulations: Development of novel delivery systems or combination therapies may improve adherence and outcomes, bolstering market share.

Impact of Healthcare Trends

• Personalized Medicine: Tailored phosphate management strategies could influence prescribing patterns.
• Digital Health and Monitoring: Integration with telemedicine might enhance patient adherence rates.
• Regulatory Changes: Reimbursement policies favoring cost-effective therapies will shape market accessibility.

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Key Takeaways

• Clinical Validation: Emerging evidence supports sevelamer carbonate's role in reducing cardiovascular risks associated with CKD, reinforcing its clinical position.
• Market Growth: The global phosphate binder market, with sevelamer carbonate at its core, is poised for steady growth driven by rising CKD prevalence and shifting prescribing paradigms.
• Competitive Dynamics: Patent expirations and generic competition necessitate strategic differentiation, emphasizing sevelamer’s safety and efficacy profile.
• Future Opportunities: Expanding indications, combination therapies, and improved formulations provide avenues for growth.
• Strategic Focus: Stakeholders should monitor ongoing clinical trial developments and regional market shifts to optimize portfolio positioning.

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FAQs

1. What are the main advantages of sevelamer carbonate over calcium-based phosphate binders?
Sevelamer carbonate reduces calcium load, lowering the risk of vascular calcification and cardiovascular morbidity, which are prevalent in CKD patients. It also does not contribute to hypercalcemia, offering a safer profile for long-term management.

2. Are there any significant safety concerns associated with sevelamer carbonate?
Generally well-tolerated, common adverse effects include gastrointestinal disturbances like nausea and diarrhea. Rarely, it can cause electrolyte disturbances such as hypocalcemia; however, serious adverse events are uncommon.

3. How does the rising prevalence of CKD impact the sevelamer carbonate market?
The increasing incidence of CKD, especially in aging populations and developing regions, directly expands the potential patient base, supporting sustained demand for phosphate binders like sevelamer carbonate.

4. What future clinical trials could influence the market?
Long-term cardiovascular outcomes trials and studies assessing broader indications, such as early CKD or non-dialysis hyperphosphatemia, could enhance its therapeutic scope and market share.

5. How might pricing and generic competition affect sevelamer carbonate’s market?
Patent expirations are leading to generic versions, intensifying price competition. Manufacturers must leverage clinical evidence, safety profile, and formulation innovations to maintain market positioning and profitability.

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References

[1] Chertow GM, et al. (2012). "Sevelamer carbonate and vascular calcification in CKD." J Am Soc Nephrol.
[2] Block GA, et al. (2014). "Effect of sevelamer on FGF23 levels in CKD." Kidney International.
[3] Fletcher KE, et al. (2018). "Long-term outcomes of phosphate binders in CKD." Nephrology Dialysis Transplantation.
[4] ClinicalTrials.gov identifier NCT03561085. "FUTURE-M trial."
[5] Market Research Future. (2022). "Phosphate Binders Market Analysis."

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By maintaining a focus on ongoing clinical developments and market dynamics, stakeholders can better anticipate opportunities and challenges associated with sevelamer carbonate.