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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR SEVELAMER CARBONATE


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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NCT00364000 ↗ Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate Withdrawn Romanian Society of Nephrology N/A 2012-01-01 End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel calcifications,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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sevelamer Carbonate

Condition Name

Condition Name for Sevelamer Carbonate
Intervention Trials
Hyperphosphatemia 18
Chronic Kidney Disease 15
Kidney Failure, Chronic 4
End Stage Renal Disease 4
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Condition MeSH

Condition MeSH for Sevelamer Carbonate
Intervention Trials
Kidney Diseases 37
Renal Insufficiency, Chronic 32
Hyperphosphatemia 20
Kidney Failure, Chronic 12
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Clinical Trial Locations for Sevelamer Carbonate

Trials by Country

Trials by Country for Sevelamer Carbonate
Location Trials
United States 145
China 17
Germany 7
United Kingdom 6
France 5
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Trials by US State

Trials by US State for Sevelamer Carbonate
Location Trials
New York 12
California 11
Texas 8
Pennsylvania 7
Illinois 7
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Clinical Trial Progress for Sevelamer Carbonate

Clinical Trial Phase

Clinical Trial Phase for Sevelamer Carbonate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 19
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Sevelamer Carbonate
Clinical Trial Phase Trials
Completed 40
Terminated 4
Unknown status 3
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Clinical Trial Sponsors for Sevelamer Carbonate

Sponsor Name

Sponsor Name for Sevelamer Carbonate
Sponsor Trials
Genzyme, a Sanofi Company 17
Shire 8
Ardelyx 4
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Sponsor Type

Sponsor Type for Sevelamer Carbonate
Sponsor Trials
Industry 49
Other 30
NIH 2
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Sevelamer Carbonate: Clinical Trials, Market Analysis, and Projections

Introduction

Sevelamer carbonate is a phosphate binder used to control serum phosphorus levels in patients with chronic kidney disease (CKD), particularly those on dialysis. This article will delve into recent clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Comparison with Other Phosphate Binders

A recent phase III study compared the efficacy and safety of sucroferric oxyhydroxide (SFOH) with sevelamer carbonate in controlling serum phosphorus in Chinese dialysis patients. The study found that SFOH was non-inferior to sevelamer carbonate in reducing serum phosphorus levels over 12 weeks. Additionally, SFOH had a lower pill burden and achieved target serum phosphorus levels earlier than sevelamer carbonate[1].

Mortality and Clinical Outcomes

A prospective cohort study published in the Journal of Clinical Medicine found that the administration of sevelamer was independently associated with lower all-cause and cardiovascular mortality in patients with CKD stages 4 and 5 who were not on dialysis. This study highlights the potential long-term benefits of sevelamer in managing CKD[4].

Historical Comparisons

Genzyme Corporation's launch of Renvela (sevelamer carbonate) in the U.S. in 2008 was based on clinical studies that showed Renvela controlled serum phosphorus levels equally to Renagel (sevelamer hydrochloride) within recommended ranges. This established sevelamer carbonate as a viable treatment option for dialysis patients[3].

Market Analysis

Global Market Size and Forecast

The global sevelamer carbonate market is expected to experience significant growth from 2023 to 2031. The market size is projected to increase substantially, driven by the increasing prevalence of hyperphosphatemia in patients with CKD. The market is segmented by type (purity ≥99% and <99%) and application (tablets and oral suspension), with the ≥98% purity segment anticipated to register significant revenue growth due to its increased usage in medical treatments[2][5].

Market Dynamics

The sevelamer carbonate market is influenced by several factors, including product pricing, national and regional market penetration, and consumer behavior. The report from Market Research Intellect highlights that the market dynamics are favorable, with drivers such as the growing need for effective phosphate control in CKD patients and restraints like competition from other phosphate binders. The market also faces opportunities such as expanding into new geographical regions and challenges like regulatory approvals and market competition[2].

Key Players and Regional Markets

Genzyme Corporation, now part of Sanofi, has been a key player in the sevelamer carbonate market. The company has secured approvals and launched the product in various regions, including the U.S., Europe, and South America. The market is expected to grow significantly in regions like North America, Europe, and Asia-Pacific, driven by the increasing incidence of CKD and the need for effective phosphate control[3][5].

Projections and Future Outlook

Revenue Growth

The sevelamer carbonate market is projected to register a rapid revenue CAGR during the forecast period from 2023 to 2031. This growth is attributed to the drug's effectiveness in treating hyperphosphatemia, its convenience in terms of dosing, and its lower risk of hypercalcemia and parathyroid suppression compared to other phosphate binders[5].

Increasing Demand

The demand for sevelamer carbonate is expected to increase due to its launch as an effective phosphate-control medicine. The drug's ability to manage serum phosphorus levels without the adverse effects associated with calcium-based binders is likely to boost its demand in the treatment of CKD patients[5].

Geographical Expansion

The market is expected to expand into new geographical regions, driven by the growing need for CKD management. Companies are anticipated to pursue additional approvals internationally, further increasing the market reach of sevelamer carbonate[3].

Safety and Tolerability

Clinical Safety Data

Studies have consistently shown that sevelamer carbonate has a favorable safety and tolerability profile. The phase III study comparing SFOH and sevelamer carbonate found no new safety signals for sevelamer carbonate, aligning with previous studies[1].

Long-term Benefits

The association of sevelamer with lower mortality rates, as observed in the prospective cohort study, underscores its long-term safety and efficacy in managing CKD patients[4].

Key Takeaways

  • Efficacy: Sevelamer carbonate is effective in controlling serum phosphorus levels, comparable to other phosphate binders like SFOH.
  • Mortality Benefits: Sevelamer use is associated with lower all-cause and cardiovascular mortality in CKD patients.
  • Market Growth: The global sevelamer carbonate market is projected to experience significant growth from 2023 to 2031.
  • Safety: Sevelamer carbonate has a favorable safety and tolerability profile, with no new safety signals observed in recent studies.
  • Geographical Expansion: The market is expected to expand into new regions, driven by the growing need for CKD management.

FAQs

What is the primary use of sevelamer carbonate?

Sevelamer carbonate is primarily used to control serum phosphorus levels in patients with chronic kidney disease, especially those on dialysis.

How does sevelamer carbonate compare to other phosphate binders?

Sevelamer carbonate has been shown to be non-inferior to other phosphate binders like sucroferric oxyhydroxide in controlling serum phosphorus levels and has a lower pill burden.

What are the long-term benefits of using sevelamer carbonate?

Sevelamer carbonate is associated with lower all-cause and cardiovascular mortality in patients with CKD stages 4 and 5 who are not on dialysis.

What drives the growth of the sevelamer carbonate market?

The market growth is driven by the increasing prevalence of hyperphosphatemia in CKD patients, the drug's effectiveness, and its convenience in terms of dosing.

Which regions are expected to see significant growth in the sevelamer carbonate market?

The market is expected to grow significantly in regions like North America, Europe, and Asia-Pacific, driven by the increasing incidence of CKD.

Sources

  1. A Randomised, Open-Label, Multicentre, 12-Week Phase III Study. PubMed, 20 July 2023.
  2. Global Sevelamer Carbonate Market Size, Scope And Forecast Report. Market Research Intellect, December 2024.
  3. Genzyme Corporation Launches Renvela(R) in the U.S. for Dialysis Patients. BioSpace, 6 March 2008.
  4. Sevelamer Use and Mortality in People with Chronic Kidney Disease Stages 4 and 5 Not on Dialysis. MDPI, 12 December 2023.
  5. Sevelamer Carbonate Market - Reports and Data. Reports and Data.

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