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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR RENAGEL


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All Clinical Trials for Renagel

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00018135 ↗ Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals Completed National Center for Research Resources (NCRR) N/A 1969-12-31 Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the blood and a secondary increase in the iPTH level. This chronic elevation in iPTH can have adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease the absorption of phosphorus present in the normal diet. Some preliminary studies have indicated that the iPTH level may change based on the amount of phosphorus present in a meal prior to any significant absorption of phosphorus. If this is true in hemodialysis patients, then the timing of the administration of phosphate binders in relation to the ingestion of meals needs to be considered
NCT00196755 ↗ Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis Completed Genzyme, a Sanofi Company Phase 3 2004-12-01 The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.
NCT00211939 ↗ CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients Completed Nabi Biopharmaceuticals Phase 4 2005-01-01 The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive technique, electron beam computed tomography (CT) scanning, to measure calcium in the coronary arteries, the aortic valve, and the mitral valve.
NCT00324571 ↗ Dialysis Clinical Outcomes Revisited (DCOR) Trial Completed Genzyme, a Sanofi Company Phase 4 2001-03-01 This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder. Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.
NCT00436683 ↗ Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia Completed Ineos Healthcare Limited Phase 2 2007-02-01 Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb. The purpose of this study is to determine how well a range of different doses of fermagate are tolerated by the subjects in the trial.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Renagel

Condition Name

Condition Name for Renagel
Intervention Trials
Chronic Kidney Disease 5
Hemodialysis 2
Hyperphosphatemia 2
Chronic Kidney Failure 2
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Condition MeSH

Condition MeSH for Renagel
Intervention Trials
Kidney Diseases 9
Renal Insufficiency, Chronic 9
Kidney Failure, Chronic 7
Renal Insufficiency 6
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Clinical Trial Locations for Renagel

Trials by Country

Trials by Country for Renagel
Location Trials
United States 67
France 12
United Kingdom 12
Italy 5
Brazil 3
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Trials by US State

Trials by US State for Renagel
Location Trials
Texas 4
Missouri 4
Illinois 4
Colorado 3
California 3
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Clinical Trial Progress for Renagel

Clinical Trial Phase

Clinical Trial Phase for Renagel
Clinical Trial Phase Trials
Phase 4 5
Phase 3 5
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Renagel
Clinical Trial Phase Trials
Completed 16
Terminated 2
Withdrawn 1
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Clinical Trial Sponsors for Renagel

Sponsor Name

Sponsor Name for Renagel
Sponsor Trials
Genzyme, a Sanofi Company 4
Ineos Healthcare Limited 2
Gulhane School of Medicine 2
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Sponsor Type

Sponsor Type for Renagel
Sponsor Trials
Other 12
Industry 11
NIH 2
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Clinical Trials, Market Analysis, and Projections for Phosphate Binders: A Focus on Renagel and Emerging Alternatives

Introduction to Hyperphosphatemia and Phosphate Binders

Hyperphosphatemia, a condition characterized by elevated phosphate levels in the blood, is a significant concern for patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). Phosphate binders are crucial in managing this condition by reducing phosphate absorption from the diet.

Renagel (Sevelamer) Overview

Renagel, also known as sevelamer, is a widely used phosphate binder. Here are some key points about Renagel:

  • Mechanism of Action: Sevelamer works by binding to phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream[5].
  • Clinical Use: It is commonly prescribed for patients with CKD and ESRD to manage hyperphosphatemia[5].

Clinical Trials and Efficacy of Sevelamer

While specific recent clinical trials on Renagel itself may not be highlighted, its efficacy has been well-established over the years. Here are some insights from related studies:

  • Comparison with Other Phosphate Binders: Studies have shown that sevelamer is effective in reducing serum phosphate levels, although it may have a higher pill burden compared to newer alternatives. For instance, the PHREEDOM trial involving XPHOZAH (tenapanor) included a safety control arm with sevelamer, demonstrating that both treatments can effectively manage serum phosphate levels, but with different profiles[1].

Emerging Alternatives: XPHOZAH and Renazorb

XPHOZAH (Tenapanor)

  • Clinical Trials: XPHOZAH has undergone extensive clinical trials, including the BLOCK, PHREEDOM, and AMPLIFY studies. These trials have shown that XPHOZAH consistently lowers serum phosphate levels in patients with CKD on maintenance dialysis, with a favorable safety profile. The NORMALIZE and OPTIMIZE trials further support its long-term safety and efficacy[1][4].
  • Mechanism of Action: XPHOZAH is the first and only phosphate absorption inhibitor (PAI), offering a novel mechanism of action compared to traditional phosphate binders[4].

Renazorb (Lanthanum Dioxycarbonate)

  • Clinical Development: Renazorb, developed by Unicycive Therapeutics, is currently in clinical development. Market research indicates high prescribing intent among nephrologists due to its high phosphate binding capacity and reduced pill burden[2][3].
  • Market Research Findings: A discrete-choice model analysis involving 100 US-based nephrologists showed that Renazorb is likely to be prescribed for a significant portion of dialysis patients, highlighting its potential as a best-in-class phosphate binder[3].

Market Analysis and Projections

Sevelamer Market

  • Current Market: The global sevelamer market is valued at $235 million in 2025 and is expected to grow to $387 million by 2033, with a CAGR of 6.2%. This growth is driven by the increasing prevalence of CKD and ESRD[5].
  • Market Trends: There is a trend towards adopting sevelamer as an alternative to calcium-based phosphate binders due to its lower risk of side effects. Advances in drug delivery technology, such as oral suspensions and sustained-release tablets, are also contributing to market growth[5].

Emerging Market Opportunities

  • XPHOZAH and Renazorb: Both XPHOZAH and Renazorb are poised to capture significant market share due to their unique profiles. XPHOZAH, with its novel mechanism of action and favorable clinical data, and Renazorb, with its high phosphate binding capacity and reduced pill burden, address key unmet needs in hyperphosphatemia management[1][2][3].
  • Global Market Potential: The hyperphosphatemia treatment market exceeds one billion dollars in the U.S. and is more than double that worldwide. Companies like Ardelyx and Unicycive are focusing on global commercial strategies to capitalize on this substantial opportunity[2][3].

Unmet Needs in Hyperphosphatemia Management

  • Patient Adherence: One of the greatest challenges in managing hyperphosphatemia is low patient adherence to prescribed phosphate binders, primarily due to high pill burden. Newer alternatives like Renazorb and XPHOZAH aim to address this issue with reduced pill burdens and improved compliance[2][3].
  • Efficacy and Tolerability: Nephrologists also highlight the need for greater efficacy, better tolerability, and less frequent dosing. These attributes are being met by emerging treatments, enhancing the overall management of hyperphosphatemia[3].

Key Takeaways

  • Renagel (Sevelamer) remains a staple in phosphate binder therapy but faces competition from newer alternatives.
  • XPHOZAH (Tenapanor) and Renazorb (Lanthanum Dioxycarbonate) are emerging as promising treatments with unique benefits, including reduced pill burden and novel mechanisms of action.
  • Market Growth: The phosphate binder market is expected to grow significantly, driven by the increasing prevalence of CKD and ESRD.
  • Patient Compliance: Addressing patient adherence through reduced pill burden and improved tolerability is a key focus for new treatments.

FAQs

What is the primary mechanism of action of Renagel (Sevelamer)?

Renagel works by binding to phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream.

How do XPHOZAH and Renazorb differ from traditional phosphate binders?

XPHOZAH is the first phosphate absorption inhibitor (PAI), while Renazorb has a high phosphate binding capacity and a reduced pill burden, addressing key unmet needs in hyperphosphatemia management.

What are the main challenges in managing hyperphosphatemia with current phosphate binders?

The main challenges include low patient adherence due to high pill burden, and the need for greater efficacy, better tolerability, and less frequent dosing.

What is the projected market growth for the phosphate binder market?

The global sevelamer market is expected to grow from $235 million in 2025 to $387 million by 2033, with a CAGR of 6.2%.

How do emerging treatments like XPHOZAH and Renazorb address the unmet needs in hyperphosphatemia management?

These treatments offer reduced pill burden, improved compliance, and in the case of XPHOZAH, a novel mechanism of action, addressing key unmet needs such as low patient adherence and the need for greater efficacy and better tolerability.

Sources

  1. Ardelyx Presents Positive Data Further Supporting Efficacy and Safety of XPHOZAH® (tenapanor) in Patients with CKD on Maintenance Dialysis. Ardelyx.
  2. Unicycive Reports Key Findings from Market Research with Nephrologists. Unicycive Therapeutics.
  3. Unicycive Reports Key Findings from Market Research with Nephrologists. GlobeNewswire.
  4. Ardelyx Announces Publication of Two Plain Language Summaries from XPHOZAH® (tenapanor) Clinical Trials. Ardelyx.
  5. Sevelamer 6.2 CAGR Growth Analysis 2025-2033. Data Insights Market.

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