CLINICAL TRIALS PROFILE FOR SUCROFERRIC OXYHYDROXIDE

All Clinical Trials for Sucroferric Oxyhydroxide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02687594 ↗	Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis (HD) or Peritoneal Dialysis (PD)	Completed	Vifor Fresenius Medical Care Renal Pharma		2016-04-06	An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide, sucrose, and starches. It was well tolerated in the clinical development program. The approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal dialysis). It is of major interest to observe the drug in daily use outside of controlled trial settings. The Marketing Authorisation Holder wishes to obtain further systematic data within a non-interventional study to investigate short and long-term safety. Effectiveness and Treatment adherence during real-life use will be evaluated.
NCT02688764 ↗	A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia	Terminated	Vifor Fresenius Medical Care Renal Pharma	Phase 3	2016-05-26	This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).
NCT03010072 ↗	The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum	Completed	Vifor Fresenius Medical Care Renal Pharma	Phase 2	2017-06-09	This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia.
NCT03010072 ↗	The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum	Completed	Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2	2017-06-09	This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia.

Clinical Trial Conditions for Sucroferric Oxyhydroxide

Condition Name

Condition Name for Sucroferric Oxyhydroxide
Intervention	Trials
Hyperphosphatemia	5
Chronic Kidney Disease Requiring Chronic Dialysis	1
Endstage Renal Disease	1
Hypoalbuminemia	1

Condition MeSH

Condition MeSH for Sucroferric Oxyhydroxide
Intervention	Trials
Hyperphosphatemia	5
Renal Insufficiency, Chronic	2
Kidney Failure, Chronic	1
Calcinosis	1

Clinical Trial Locations for Sucroferric Oxyhydroxide

Trials by Country

Trials by Country for Sucroferric Oxyhydroxide
Location	Trials
United States	40
Germany	2
France	2
Netherlands	1
Lithuania	1

Trials by US State

Trials by US State for Sucroferric Oxyhydroxide
Location	Trials
North Carolina	2
New York	2
New Mexico	2
New Jersey	2
Missouri	2

Clinical Trial Progress for Sucroferric Oxyhydroxide

Clinical Trial Phase

Clinical Trial Phase for Sucroferric Oxyhydroxide
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Sucroferric Oxyhydroxide
Clinical Trial Phase	Trials
Completed	5
Terminated	1

Clinical Trial Sponsors for Sucroferric Oxyhydroxide

Sponsor Name

Sponsor Name for Sucroferric Oxyhydroxide
Sponsor	Trials
Vifor Fresenius Medical Care Renal Pharma	4
Prim. Priv. Doz. Dr. Daniel Cejka	1
Ardelyx	1

Sponsor Type

Sponsor Type for Sucroferric Oxyhydroxide
Sponsor	Trials
Industry	5
Other	2

Sucroferric Oxyhydroxide: Clinical Trials Update, Market Analysis, and Projections

Introduction

Sucroferric oxyhydroxide (SO), marketed as Velphoro, is a novel iron-based phosphate binder designed to manage hyperphosphatemia in patients undergoing dialysis due to chronic kidney disease (CKD). This article provides an update on the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Efficacy and Safety in Real-Life Settings

The VELREAL multicentre study, an observational, retrospective analysis, evaluated the use, efficacy, and safety of SO in real clinical practice. The study involved 220 patients from 11 Spanish centres and demonstrated that SO significantly reduced serum phosphate levels by 20%, improved therapeutic adherence, and reduced the number of tablets required. It also showed benefits in controlling secondary hyperparathyroidism and improving nutritional status[1].

Long-Term Safety and Effectiveness

The VERIFIE study, a post-marketing analysis, assessed the long-term safety and effectiveness of SO in Spanish patients undergoing hemodialysis and peritoneal dialysis. The study found that SO maintained a favorable effectiveness profile, with a significant reduction in serum phosphorus levels and a low daily pill burden. Adverse drug reactions were mostly gastrointestinal and of mild to moderate severity[2].

Comparative Studies

A phase III study compared the efficacy and safety of SO with sevelamer carbonate in controlling serum phosphorus in Chinese dialysis patients. The study concluded that SO was non-inferior to sevelamer carbonate and achieved target serum phosphorus levels earlier with a lower pill burden. The safety and tolerability profile of SO was consistent with previous studies[4].

Market Analysis

Market Positioning

Sucroferric oxyhydroxide has carved a niche in the phosphate binder market due to its potent phosphorus-binding capacity over a wide pH range, allowing for a reduced number of tablets. This feature has been shown to improve patient compliance, a critical factor in managing hyperphosphatemia[2].

Cost-Effectiveness

An economic evaluation analysis suggested that SO could result in substantial cost-savings by reducing hospital admission costs attributable to hyperphosphatemia-related complications. This makes SO an attractive option for healthcare systems looking to manage CKD patients more efficiently[5].

Patient Preference

Studies have highlighted that patients prefer SO over other phosphate binders due to its lower pill burden and improved tolerability. For instance, the VERIFIE study noted that patients received a mean daily dose of 1.98 tablets/day, which is significantly lower than other phosphate binders[2].

Market Projections

Growing Demand

The global market for phosphate binders is expected to grow due to the increasing prevalence of CKD and the need for effective management of hyperphosphatemia. SO, with its favorable efficacy and safety profile, is well-positioned to capture a significant share of this market.

Competitive Landscape

While SO faces competition from other phosphate binders like sevelamer carbonate and newer agents such as oxylanthanum carbonate (OLC), its unique benefits, such as a lower pill burden and improved patient compliance, are likely to sustain its market presence. The preference of patients for SO, as evidenced by the VERIFIE study, further supports its market potential[2][3].

Regulatory Environment

SO has been approved in the United States and Europe, and its continued use and positive outcomes in clinical practice are expected to reinforce its regulatory standing. Any new regulatory approvals or expansions into additional markets will further bolster its market position.

Key Takeaways

• Clinical Efficacy: SO has demonstrated significant reductions in serum phosphate levels and improvements in therapeutic adherence and nutritional status.
• Safety Profile: SO has a favorable safety profile with mostly mild to moderate adverse effects, primarily gastrointestinal.
• Market Position: SO's unique benefits, such as a lower pill burden, position it favorably in the phosphate binder market.
• Cost-Effectiveness: SO can lead to substantial cost-savings by reducing hospital admissions related to hyperphosphatemia.
• Patient Preference: Patients prefer SO due to its lower pill burden and improved tolerability.

FAQs

What is Sucroferric Oxyhydroxide?

Sucroferric oxyhydroxide (SO) is an iron-based phosphate binder used to manage hyperphosphatemia in patients with chronic kidney disease (CKD) undergoing dialysis.

How does SO compare to other phosphate binders?

SO has been shown to be non-inferior to sevelamer carbonate in reducing serum phosphorus levels and offers a lower pill burden, improving patient compliance[2][4].

What are the common side effects of SO?

The most common side effects of SO are gastrointestinal disorders, which are generally mild to moderate in severity[2].

How does SO impact patient compliance?

SO's lower pill burden significantly improves patient compliance, as evidenced by increased adherence rates in clinical studies[1][2].

Is SO cost-effective?

Yes, SO can lead to substantial cost-savings by reducing hospital admissions related to hyperphosphatemia, making it a cost-effective option for managing CKD patients[5].

Sources

1. Clinical Kidney Journal: "The efficacy and safety of sucroferric oxyhydroxide (SO) have been reported in clinical trials. However, real-life data are scarce. This study presents data on the use, efficacy and safety of SO in real clinical practice."
2. Nefrología: "This sub-analysis of the VERIFIE study evaluates the long-term safety and effectiveness of sucroferric oxyhydroxide (OHS) in Spanish patients."
3. Unicycive Therapeutics: "Unicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC)"
4. PubMed: "A Randomised, Open-Label, Multicentre, 12-Week Phase III Study to Investigate the Efficacy and Safety of Sucroferric Oxyhydroxide (SFOH) versus Sevelamer Carbonate in Controlling Serum Phosphorus in Adult Chinese Dialysis Patients with Hyperphosphataemia"
5. Value in Health Journal: "PUK11 Economic Evaluation Analysis of Using Sucroferric Oxyhydroxide"