CLINICAL TRIALS PROFILE FOR VELPHORO

All Clinical Trials for VELPHORO

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.
NCT04046263 ↗	Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients	Completed	University of Colorado, Denver	Phase 4	2020-02-01	Prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients.

Clinical Trial Conditions for VELPHORO

Condition Name

Condition Name for VELPHORO
Intervention	Trials
Hyperphosphatemia	3
Endstage Renal Disease	1
Hypoalbuminemia	1
Peritoneal Dialysis Complication	1

Condition MeSH

Condition MeSH for VELPHORO
Intervention	Trials
Hyperphosphatemia	3
Calcinosis	1
Hypoalbuminemia	1
Renal Insufficiency, Chronic	1

Clinical Trial Locations for VELPHORO

Trials by Country

Trials by Country for VELPHORO
Location	Trials
United States	18
France	2
Germany	2
Lithuania	1
Italy	1

Trials by US State

Trials by US State for VELPHORO
Location	Trials
New Jersey	1
Missouri	1
Michigan	1
Iowa	1
Georgia	1

Clinical Trial Progress for VELPHORO

Clinical Trial Phase

Clinical Trial Phase for VELPHORO
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for VELPHORO
Clinical Trial Phase	Trials
Completed	3
Terminated	1

Clinical Trial Sponsors for VELPHORO

Sponsor Name

Sponsor Name for VELPHORO
Sponsor	Trials
Vifor Fresenius Medical Care Renal Pharma	3
Prim. Priv. Doz. Dr. Daniel Cejka	1
University of Colorado, Denver	1

Sponsor Type

Sponsor Type for VELPHORO
Sponsor	Trials
Industry	3
Other	2

VELPHORO (sucroferric oxyhydroxide) | Clinical-trials update and market analysis with projections

Last updated: May 6, 2026

What is VELPHORO and what is it positioned to treat?

VELPHORO is sucroferric oxyhydroxide, an oral phosphate binder indicated for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The product is positioned against non-calcium and calcium-based phosphate binders in a chronic, maintenance setting.

What clinical-trials readouts and development activity matter for the next 12–36 months?

No trial readouts or development-stage changes can be stated with precision from the information available in this workspace. A “clinical trials update” that names specific studies, endpoints, enrollment status, and dates requires source-backed facts.

What does the evidence base imply for payer and prescriber adoption?

VELPHORO’s market relevance is tied to three adoption drivers typical in CKD hyperphosphatemia formularies:

• Durability in chronic use (binding performance across long maintenance windows)
• Safety/tolerability (GI tolerability profile and iron exposure management)
• Formulary differentiation versus competing binders (especially non-calcium binders)

Those drivers determine uptake more than single-study novelty, but any quantified competitive assessment requires market inputs and current payer coverage data that are not present here.

How big is the addressable market?

The addressable market is CKD populations on dialysis with diagnosed or managed hyperphosphatemia, across major geographies (US, EU5, Japan). Market sizing is not possible to complete accurately without:

• dialysis prevalence by region,
• the proportion treated with phosphate binders,
• average annual binder-treated patient share,
• formulary mix.

No such numeric inputs are available in this workspace.

What is the competitive landscape and where does VELPHORO sit?

VELPHORO competes in phosphate binder classes that include:

• Non-calcium binders (for example sevelamer polymers)
• Calcium-based binders (for example calcium carbonate/acetate)
• Iron-based binder approaches (including products in similar mechanistic “class logic” for specific patient subsets)

A defensible competitive positioning requires verified market shares, pricing spreads, and formulary placements by class.

What is the current market outlook and a defensible projection?

A projection requires baseline revenue and a chain of assumptions (unit growth, share gains/losses, price changes, contract coverage shifts, and competitor dynamics). No revenue baseline, unit sales, or price data is available here.

Market projection framework (what must drive the model for VELPHORO)

Even without numeric inputs, the projection model for VELPHORO in phosphate binding typically follows four levers:

1. Dialysis treated prevalence

• Growth in dialysis patient counts by region
• Share of patients receiving phosphate binders

2. Within-class share

• Uptake versus non-calcium binders
• Switch rates from competitor binders driven by tolerability, pill burden, and co-morbidity

3. Net price

• Contracting outcomes (formularies, rebating, MAC dynamics where applicable)
• Geographic price regulation or channel structure

4. Lifecycle risks

• Safety label changes or post-market signals
• Patent/market exclusivity milestones
• Competition from newer agents and incremental substitutes

Without validated input numbers, no credible forward forecast can be produced.

Key Takeaways

• VELPHORO (sucroferric oxyhydroxide) is an oral phosphate binder for hyperphosphatemia in dialysis CKD.
• A clinical trials update with specific studies, endpoints, and timing cannot be completed from the information available here.
• A market analysis with quantified projections cannot be produced without validated inputs on dialysis prevalence, binder-treated share, pricing, and current market performance.

FAQs

1. What indication does VELPHORO have?
   Hyperphosphatemia in CKD patients on dialysis.

2. What class of therapy is VELPHORO?
   Oral phosphate binder therapy.

3. Who are the main competitors?
   Other phosphate binders, including calcium-based and non-calcium binders used in dialysis CKD hyperphosphatemia.

4. What drives VELPHORO adoption in dialysis formularies?
   Chronic tolerability, binding efficacy in real-world use, and contract formulary placement versus competing binders.

5. Can I get a numeric market forecast here?
   Not with the source-backed baseline and assumptions required for an accurate projection.

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References

[1] No sources were provided in this workspace.