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.

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
Kidney Diseases	4
Anemia, Iron-Deficiency	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
Indiana	2
Georgia	2
Colorado	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

Auryxia: Clinical Trials, Market Analysis, and Projections

Introduction to Auryxia

Auryxia, also known as ferric citrate, is a medication developed by Keryx Biopharmaceuticals (now part of Akebia Therapeutics) for the treatment of various conditions associated with chronic kidney disease (CKD). It has been approved by the U.S. Food and Drug Administration (FDA) for two primary indications: controlling serum phosphorus levels in patients with CKD on dialysis, and treating iron deficiency anemia in adults with CKD not on dialysis.

Clinical Trials Overview

Control of Serum Phosphorus Levels

Auryxia was initially approved in September 2014 for the control of serum phosphorus levels in patients with CKD who require dialysis. This approval was based on clinical trials that demonstrated the efficacy of ferric citrate in reducing serum phosphorus levels, a critical aspect of managing CKD[3].

Treatment of Iron Deficiency Anemia

In November 2017, the FDA approved Auryxia for an additional indication: the treatment of iron deficiency anemia in adults with CKD not on dialysis. This approval was based on a 24-week placebo-controlled Phase 3 clinical trial involving 234 adults with stage 3-5 non-dialysis dependent CKD. The trial showed significant increases in hemoglobin levels, transferrin saturation (TSAT), and serum ferritin levels in patients treated with Auryxia compared to those receiving a placebo[3][4].

Key Trial Findings

• Hemoglobin Levels: 52% of patients treated with Auryxia achieved an increase in hemoglobin levels of ≥1.0 g/dL by Week 16.
• TSAT and Ferritin: Auryxia increased mean TSAT from 20.2% to 35.6% and mean ferritin from 85.9 ng/mL to 233.5 ng/mL over the 16-week period[4].

Market Analysis

Revenue Performance

Akebia Therapeutics has reported steady revenue growth from Auryxia sales. In the first quarter of 2024, Auryxia net product revenues were $31.0 million, and in the second quarter, revenues were $41.2 million. Akebia expects Auryxia full-year 2024 net product revenues to be in line with 2023 levels[2][5].

Market Expansion

Akebia is actively engaged in contracting discussions with dialysis organizations to ensure broad access to Auryxia, particularly as phosphate binders, including Auryxia, are expected to be added to the Centers for Medicare and Medicaid Services (CMS) bundled payment for dialysis in 2025. This inclusion is anticipated to enhance the drug's market penetration and accessibility[2][5].

Competitive Landscape

The market for CKD treatments is competitive, with several drugs targeting different aspects of the disease. However, Auryxia's dual indications and its ability to address both iron deficiency anemia and serum phosphorus control position it uniquely in the market. The upcoming inclusion in the CMS dialysis bundle further strengthens its competitive stance.

Projections and Future Outlook

Revenue Projections

Given the expected inclusion in the CMS dialysis bundle and ongoing contracting efforts with dialysis organizations, Auryxia is projected to see continued revenue growth. Akebia's financial reports indicate that the company expects sufficient cash resources to support operations and invest in the launch of other products, such as Vafseo (vadadustat), through at least the next two years[2][5].

Market Growth Drivers

• Increasing CKD Prevalence: The growing prevalence of CKD and associated conditions such as iron deficiency anemia will drive the demand for effective treatments like Auryxia.
• Expanded Indications: Potential future approvals for additional indications could further expand Auryxia's market reach.
• Healthcare Policy Changes: Inclusion in the CMS dialysis bundle is a significant driver, as it will make Auryxia more accessible to patients undergoing dialysis.

Challenges and Opportunities

• Competition: The CKD treatment market is highly competitive, and Auryxia must continue to demonstrate its efficacy and safety to maintain market share.
• Regulatory Environment: Changes in healthcare policies and reimbursement structures can impact the drug's market performance.
• Patient Access Programs: Initiatives like AkebiaCares, which support patients in accessing the medication, will be crucial in ensuring that Auryxia reaches a broader patient population[4].

Expert Insights and Statistics

Clinical Efficacy

"Auryxia demonstrated significant increases in hemoglobin levels, TSAT, and serum ferritin levels in patients with CKD not on dialysis," said a spokesperson from Akebia Therapeutics. "These results underscore the drug's effectiveness in managing iron deficiency anemia in this patient population"[4].

Market Statistics

• In the second quarter of 2024, Auryxia net product revenues were $41.2 million, indicating a strong market presence[5].
• The CMS decision to include phosphate binders in the dialysis bundle is expected to impact over 500,000 patients undergoing dialysis in the U.S., potentially increasing Auryxia's market share[2].

Key Takeaways

• Clinical Efficacy: Auryxia has demonstrated significant efficacy in controlling serum phosphorus levels and treating iron deficiency anemia in CKD patients.
• Market Performance: Auryxia has shown steady revenue growth, with expectations for continued growth driven by its inclusion in the CMS dialysis bundle.
• Future Outlook: The drug's unique dual indications and upcoming market expansions position it for continued success in the CKD treatment market.

FAQs

What is Auryxia used for?

Auryxia is used for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis and for the treatment of iron deficiency anemia in adults with CKD not on dialysis.

What were the key findings of the Phase 3 clinical trial for iron deficiency anemia?

The trial showed significant increases in hemoglobin levels, TSAT, and serum ferritin levels in patients treated with Auryxia compared to those receiving a placebo.

How is Auryxia administered?

Auryxia is administered orally, typically with meals, and the dose can vary but often starts at three tablets per day.

What is the expected impact of Auryxia's inclusion in the CMS dialysis bundle?

The inclusion is expected to enhance the drug's market penetration and accessibility, particularly for patients undergoing dialysis.

What other products is Akebia Therapeutics launching, and how might they impact Auryxia's market position?

Akebia is launching Vafseo (vadadustat), which could complement Auryxia in the CKD treatment market, but the primary focus remains on ensuring broad access to Auryxia through ongoing contracting efforts.

Sources

1. Kewalramani Takes Helm at Vertex FDA Puts CKD Drug on Fast Track - Kidney News.
2. Akebia Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights - BioSpace.
3. U.S. FDA Approves Keryx Biopharma's Auryxia (ferric citrate) Tablets - BioSpace.
4. Efficacy | AURYXIA® (ferric citrate) tablets For HCPs - AuryxiaHCP.
5. Akebia Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights - PR Newswire.

Last updated: 2025-01-07