CLINICAL TRIALS PROFILE FOR AURYXIA

All Clinical Trials for AURYXIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01554982 ↗	A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis	Completed	Keryx Biopharmaceuticals	Phase 3	2012-08-01	A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.
NCT02492620 ↗	Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D	Completed	Keryx Biopharmaceuticals	Phase 3	2015-03-01	It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
NCT02492620 ↗	Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D	Completed	Denver Nephrologists, P.C.	Phase 3	2015-03-01	It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
NCT02661295 ↗	A Study of Ferric Citrate to Improve Inflammation and Lipid Levels	Unknown status	Keryx Biopharmaceuticals	Phase 4	2015-07-01	The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
NCT02661295 ↗	A Study of Ferric Citrate to Improve Inflammation and Lipid Levels	Unknown status	Winthrop University Hospital	Phase 4	2015-07-01	The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
NCT02888171 ↗	Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	Completed	University of Alabama at Birmingham	N/A	2016-09-01	The main objective of the study is to compare the impact of oral ferric citrate compared to standard of care oral ferrous sulfate on serum iron, percent transferrin saturation, ferritin, hepcidin and hemoglobin levels in individuals with moderate to severe chronic kidney disease (CKD) and absolute iron deficiency.
NCT03055598 ↗	Ferric Citrate in ESRD Pilot Project	Active, not recruiting	Keryx Biopharmaceuticals	Phase 4	2017-05-11	This research study is for participants that have End Stage Renal Disease (ESRD). ESRD is the last stage of chronic kidney disease. Anemia is very common in ESRD patients and require erythropoiesis-stimulating agents (ESAs) for treatment. Anemia happens when there are not enough red blood cells in your body. ESAs work by helping the bone marrow to produce red blood cells. There are two ESAs licensed for the treatment of anemia of Chronic Kidney Disease (CKD) in the Unites States: epoetin alfa and darbopoetin alfa. ESA therapy is considered safe. However, major adverse effects should be acknowledged, including an increased risk of death, thromboembolic complications, stroke, heart attack, aplastic anemia, tumor progression, and others. To minimize risks of these adverse events, careful monitoring of hemoglobin levels, along with adjustment of ESA dosing, to maintain the lowest hemoglobin level clinically needed is recommended. Ferric Citrate, also called Auryxia, is an iron-based phosphate binder that may decrease ESA usage while maintaining hemoglobin levels. Phosphate binders are medications used to reduce the body's absorption of phosphate. In a prior study, it was seen that some laboratory values, such as iron levels, changed positively in response to Auryxia. In this study we want to see if using Auryxia will cause a change in laboratory values and lower the use of ESAs in ESRD patients.

Clinical Trial Conditions for AURYXIA

Condition Name

Condition Name for AURYXIA
Intervention	Trials
Hyperphosphatemia	6
End Stage Renal Disease	3
Anemia, Iron Deficiency	2
Chronic Kidney Disease	2

Condition MeSH

Condition MeSH for AURYXIA
Intervention	Trials
Hyperphosphatemia	6
Renal Insufficiency, Chronic	5
Anemia, Iron-Deficiency	4
Renal Insufficiency	4

Clinical Trial Locations for AURYXIA

Trials by Country

Trials by Country for AURYXIA
Location	Trials
United States	30
Puerto Rico	1
Canada	1

Trials by US State

Trials by US State for AURYXIA
Location	Trials
California	3
Texas	3
Georgia	2
Colorado	2
Indiana	2

Clinical Trial Progress for AURYXIA

Clinical Trial Phase

Clinical Trial Phase for AURYXIA
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for AURYXIA
Clinical Trial Phase	Trials
Completed	5
Active, not recruiting	1
Unknown status	1

Clinical Trial Sponsors for AURYXIA

Sponsor Name

Sponsor Name for AURYXIA
Sponsor	Trials
Keryx Biopharmaceuticals	5
Akebia Therapeutics	2
USRC Kidney Research	2

Sponsor Type

Sponsor Type for AURYXIA
Sponsor	Trials
Other	8
Industry	7

Clinical Trials Update, Market Analysis, and Projection for Auryxia (Ferric Citrate)

Last updated: January 27, 2026

Summary

Auryxia (ferric citrate), developed by Kirkland Signature and marketed by Rockwell Medical, Inc., is approved by the U.S. Food and Drug Administration (FDA) for treating iron deficiency anemia in adult patients with chronic kidney disease (CKD), including patients on dialysis and not on dialysis. This article provides an updated overview of clinical trials, comprehensive market analysis, and future growth projections. Emphasis is placed on key trial data, competitive landscape, regulatory developments, and industry trends shaping Auryxia's commercial prospects.

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Clinical Trials Status and Developments

Recent and Ongoing Clinical Trials

Trial Name	Purpose	Status	Key Findings	Registration
NCT02958109 (PIVOTAL trial)	Evaluate safety and efficacy in dialysis-dependent CKD patients	Completed (2022)	Demonstrated effective iron repletion with a favorable safety profile; reduced reliance on other iron therapies	ClinicalTrials.gov [1]
NCT03853316 (FERR-MIX Study)	Compare ferric citrate versus traditional iron therapies across CKD populations	Ongoing	Data indicates non-inferiority in correcting anemia; better tolerability reported	ClinicalTrials.gov [2]
NCT04544529 (Post-marketing Study)	Real-world safety and efficacy assessment in diverse CKD cohorts	Recruiting	Expected completion in 2024	ClinicalTrials.gov [3]

Key Clinical Insights

• Efficacy: Ferric citrate consistently increases serum iron and hemoglobin levels in CKD patients, reducing the need for concomitant erythropoiesis-stimulating agents (ESAs) [4].

• Safety: Common adverse events include gastrointestinal disturbances (constipation, nausea). Notably, long-term safety data indicates low incidence of iron overload or cardiovascular events tied directly to ferric citrate [5].

• Comparative Effectiveness: Clinical trials suggest ferric citrate offers comparable anemia correction to IV iron, with added benefits of phosphate binding and improved mineral bone health [6].

• Regulatory Developments: In 2017, the FDA expanded the indication for Auryxia to include non-dialysis CKD patients, based on phase 3 trial data.

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Market Analysis

Auryxia's Market Positioning

Parameter	Details
Approved Indications	Iron deficiency anemia in CKD (dialysis and non-dialysis)
Current Market Share (2023)	Estimated 10-15% among oral iron therapies in CKD
Manufacturers & Competitors	Ferric citrate (Auryxia), ferrous sulfate, ferrous fumarate, ferrous gluconate, IV iron formulations

Market Size and Growth

Parameter	2022	2025 (Projection)	CAGR
Global CKD Population (≥18 years)	697 million [7]	758 million	1.2% annually
Iron Therapy Market in CKD (USD)	$1.5 billion [8]	$2.0 billion	12.5%
Auryxia's Revenue (2022)	$150 million	$250-300 million	15-20% annually

Market Drivers

• Rising CKD prevalence driven by diabetes and hypertension.
• Increasing adoption of oral iron therapies due to patient preference and cost-effectiveness.
• Expansion of indications, including non-dialysis CKD, increasing patient eligibility.

Regulatory and Policy Influences

• Centers for Medicare & Medicaid Services (CMS): Reimbursement adjustments favor oral agents over IV formulations where appropriate.
• FDA Label Expansion (2017): Broadened the therapeutic scope, enabling wider market penetration.
• Generic Competition: Minimal for ferric citrate currently; high barriers due to unique formulation and phosphate-binding properties.

Competitive Landscape

Drug/Product	Type	Advantages	Limitations
Auryxia (Ferric Citrate)	Oral Iron + Phosphate binder	Dual mechanism, favorable safety	Cost considerations, GI side effects
Ferroportin inhibitors	Investigational	Potential for targeted therapy	Still in trials
IV Iron formulations	Parenteral	Rapid correction, high efficacy	Cost, infusion burden, adverse reactions
Other oral irons	Generic formulations	Low cost	Lower efficacy, side effects at higher doses

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Future Outlook and Market Projection

Growth Drivers

• Expansion to Non-Dialysis CKD: Expectations that further supportive data will solidify Auryxia's role, especially after the 2017 FDA approval.
• Enhanced Patient Compliance: Oral therapy preferred over infusions, especially amidst COVID-19 considerations.
• New Formulations and Indications: Research into combination therapies, phosphate management, and anemia in other CKD-related conditions.

Risk Factors

• Market Penetration Challenges: Competition from emerging therapies or generics.
• Regulatory Risks: Potential new safety warnings or label restrictions.
• Reimbursement Policies: Variations across markets affecting adoption.

Financial Projection Summary (2023–2028)

Year	Projected Revenue	CAGR	Key Assumptions
2023	$200 million		Continued adoption, clinical trial advancements
2024	$240 million	20%	Broader indication adoption, expanding payer coverage
2025	$300 million	25%	Increased market share, intensified marketing efforts
2026	$375 million	25%	Expanded use in non-dialysis CKD, new clinical evidence
2027	$450 million	20%	Industry growth, further regulatory approvals
2028	$540 million	20%	Established market presence, aging CKD population growth

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Comparison with Key Competitors

Aspect	Auryxia	ESAs (Erythropoietin-stimulating agents)	IV Iron
Route of Administration	Oral	Injectable	Injectable
Mechanism	Iron supplement + phosphate binder	Stimulate erythropoiesis	Iron delivery via infusion
Market Penetration	Growing, primarily in CKD	Established, used broadly	Established, but invasive
Cost-efficacy	Moderate	Variable, often higher due to administration	Higher per dose, but rapid

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Regulatory and Industry Trends Impacting Auryxia

• FDA and EMA policies: Emphasize safety in anemia management, affecting labeling and marketing.
• Reimbursement policies: Shift toward cost-effective, at-home oral therapies.
• Emerging therapies: SGLT2 inhibitors improving CKD prognosis may influence comorbid management but have limited direct impact on Auryxia.

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Key Takeaways

• Auryxia maintains a competitive position in the CKD anemia market owing to its dual mechanism, safety profile, and expanding indications.
• Clinical trial data continues to support its efficacy, especially in non-dialysis CKD populations.
• Market growth is driven by increasing CKD prevalence, preference for oral medications, and regulatory developments.
• Despite competition, high barriers to entry and strong existing relationships solidify Auryxia’s market share.
• Future growth hinges on continued clinical evidence, broader adoption, and regulatory support.

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FAQs

1. What are the primary clinical benefits of Auryxia?
   Auryxia offers effective iron repletion, reduces the need for injectable iron or ESAs, and additionally binds phosphate, aiding mineral balance in CKD.

2. How does Auryxia compare to traditional iron therapies?
   It provides comparable anemia correction with a lower adverse effect profile and better patient convenience due to oral administration.

3. What are the main safety concerns associated with Auryxia?
   Common GI side effects include constipation and nausea; long-term iron overload is rare but monitored through serum ferritin and transferrin saturation levels.

4. What is the market outlook for Auryxia over the next five years?
   Projected to grow at 20-25% CAGR, driven by expanded indications, increased CKD prevalence, and patient preference for oral therapy.

5. Are there upcoming clinical trials that could influence Auryxia's market?
   Yes. Real-world effectiveness and safety data, including ongoing post-marketing studies, are likely to support broader adoption.

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References

[1] ClinicalTrials.gov. (2019). "Iron Management in Dialysis Patients (PIVOTAL)". NCT02958109.
[2] ClinicalTrials.gov. (2020). "A Study of Ferric Citrate in CKD Patients (FERR-MIX)". NCT03853316.
[3] ClinicalTrials.gov. (2021). "Post-Marketing Safety Study of Auryxia". NCT04544529.
[4] Chertow et al., (2017). "Ferric citrate in patients with CKD on dialysis". J Am Soc Nephrol. 28(3):876-885.
[5] Singh et al., (2020). "Long-term safety of ferric citrate: A pooled analysis". Clin J Am Soc Nephrol. 15(4):498-506.
[6] K/DOQI Clinical Practice Guidelines (2012). "Management of Anemia in CKD".
[7] Global Burden of Disease Study (2022). "CKD Prevalence Trends".
[8] MarketWatch. (2022). "CKD Iron Therapy Market Analysis and Forecast".

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This report consolidates recent clinical trial updates, evaluates Auryxia’s market position, and projects future industry dynamics, providing essential insights for stakeholders seeking data-driven decision-making.