CLINICAL TRIALS PROFILE FOR PHOSLO

All Clinical Trials for Phoslo

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00211978 ↗	EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease)	Completed	Nabi Biopharmaceuticals	Phase 3	2005-05-01	The purpose of this study is to determine if calcium acetate (PhosLo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.
NCT00742820 ↗	Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers	Completed	Fresenius Medical Care North America	Phase 1	2008-08-01	To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.
NCT01074125 ↗	A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease	Completed	Collaborative Study Group (CSG)	Phase 3	2010-05-01	This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.
NCT01074125 ↗	A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease	Completed	Keryx Biopharmaceuticals	Phase 3	2010-05-01	This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.

Clinical Trial Conditions for Phoslo

Condition Name

Condition Name for Phoslo
Intervention	Trials
Hyperphosphatemia	4
Hyperparathyroidism, Secondary	2
Kidney Failure	2
Arteriosclerosis	1

Condition MeSH

Condition MeSH for Phoslo
Intervention	Trials
Kidney Diseases	4
Hyperphosphatemia	4
Kidney Failure, Chronic	3
Renal Insufficiency, Chronic	3

Clinical Trial Locations for Phoslo

Trials by Country

Trials by Country for Phoslo
Location	Trials
United States	37
Puerto Rico	2
Italy	1
Israel	1

Trials by US State

Trials by US State for Phoslo
Location	Trials
Texas	4
New York	3
Ohio	3
Wisconsin	2
Tennessee	2

Clinical Trial Progress for Phoslo

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Phoslo
Clinical Trial Phase	Trials
Completed	5
Terminated	1
Unknown status	1

Clinical Trial Sponsors for Phoslo

Sponsor Name

Sponsor Name for Phoslo
Sponsor	Trials
Nabi Biopharmaceuticals	2
Keryx Biopharmaceuticals	2
Amgen	1

Sponsor Type

Sponsor Type for Phoslo
Sponsor	Trials
Industry	7
Other	4

PhosLo: Clinical Trials, Market Analysis, and Projections

Introduction to PhosLo

PhosLo, also known as calcium acetate, is a phosphate binder used to reduce serum phosphorus levels in patients with end-stage renal disease (ESRD) undergoing hemodialysis. Here, we will delve into the clinical trials, market analysis, and future projections for PhosLo.

Clinical Trials Experience

PhosLo has been extensively studied in various clinical trials to assess its efficacy and safety.

Open-Label and Placebo-Controlled Studies

In a 3-month, open-label, non-randomized study involving 98 ESRD hemodialysis patients, PhosLo demonstrated its effectiveness in reducing serum phosphorus levels. Additionally, a two-week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients further validated its efficacy. These studies showed that PhosLo was generally well tolerated, with common adverse reactions including nausea, vomiting, and hypercalcemia[1][4].

Adverse Reactions

The clinical trials highlighted that the most common adverse reactions (>2% on treatment) were nausea, vomiting, and hypercalcemia. Hypercalcemia, in particular, is a significant concern and can be managed by adjusting the dose or temporarily discontinuing therapy. Severe hypercalcemia may require acute hemodialysis and discontinuation of PhosLo[1][4].

Market Analysis

Current Market Size and Growth

The market for phosphate binders, including PhosLo, is part of the broader calcium phosphate and phosphate salts markets. The global calcium phosphate market was valued at USD 1.13 billion in 2024 and is expected to reach USD 2.5 billion by 2037, growing at a CAGR of around 6.3% during the forecast period[2].

Phosphate Salts Market

The global phosphate salts market, which includes various applications such as water treatment, agriculture, and food processing, was valued at USD 56.6 billion in 2024. This market is projected to grow at a CAGR of over 6.6% from 2025 to 2034, reaching USD 106 billion by 2034. The U.S. phosphate salts market, driven by agriculture and food processing, is expected to contribute significantly to this growth[5].

Market Drivers and Trends

Growing Demand in Agriculture

The increasing demand for agricultural products, driven by a growing global population, is a key driver for the phosphate salts market. By 2050, the demand for food is anticipated to rise by 58% to 97%, which in turn boosts the use of bio-fertilizers and phosphate-based fertilizers[2][5].

Water Treatment and Food Processing

Phosphate salts play a crucial role in water treatment, preventing corrosion, scale, and biofilm buildup in both municipal and industrial water systems. Additionally, they are essential in food processing, particularly in the meat industry, where they enhance water retention, texture, and flavor[5].

Competitive Landscape

Emerging Alternatives

The phosphate binder market is witnessing the emergence of new alternatives. For instance, Unicycive Therapeutics' Oxylanthanum Carbonate (OLC) has shown promising results in clinical trials. OLC reduced the median daily pill burden by half compared to prior phosphate binder therapies and was preferred by patients over 4 to 1. This could potentially impact the market share of existing phosphate binders like PhosLo[3].

Future Projections

Market Growth

Given the growing demand for phosphate-based products in agriculture, water treatment, and food processing, the market for phosphate binders is expected to continue growing. The calcium phosphate market's projected CAGR of 6.3% from 2025 to 2037 indicates a robust future for PhosLo and similar products[2].

Technological Innovations

Technological innovations in phosphate extraction and sustainable production practices are likely to support market growth. Advanced agricultural practices and a focus on sustainable farming technologies will further drive the demand for phosphate-based fertilizers and binders[5].

Patient Satisfaction and Compliance

Ease of Use

Patient satisfaction and compliance are critical factors in the success of any medication. The introduction of new phosphate binders like OLC, which reduce pill burden and improve patient preference, may influence the market dynamics. However, PhosLo's established presence and efficacy will likely maintain its position in the market[3].

Key Takeaways

• Clinical Efficacy: PhosLo has been shown to be effective in reducing serum phosphorus levels in ESRD patients through various clinical trials.
• Market Growth: The phosphate binder market, including PhosLo, is expected to grow significantly driven by demand in agriculture, water treatment, and food processing.
• Competitive Landscape: Emerging alternatives like OLC may impact the market share of PhosLo, but its established efficacy and patient base will remain significant.
• Technological Innovations: Advances in phosphate extraction and sustainable production will support the growth of the phosphate binder market.

FAQs

What is PhosLo used for?

PhosLo (calcium acetate) is used to reduce serum phosphorus levels in patients with end-stage renal disease (ESRD) undergoing hemodialysis.

What are the common adverse reactions associated with PhosLo?

Common adverse reactions include nausea, vomiting, and hypercalcemia. Severe hypercalcemia can lead to more serious complications like confusion, delirium, and coma[1][4].

How does PhosLo compare to other phosphate binders?

PhosLo has been a standard treatment for hyperphosphatemia, but new alternatives like Oxylanthanum Carbonate (OLC) are emerging, offering reduced pill burden and improved patient preference[3].

What drives the growth of the phosphate binder market?

The growth is driven by increasing demand in agriculture, water treatment, and food processing, as well as technological innovations in phosphate extraction and sustainable production practices[2][5].

What is the projected market size for phosphate binders by 2037?

The calcium phosphate market is expected to reach USD 2.5 billion by 2037, growing at a CAGR of around 6.3% from 2025 to 2037[2].

Sources

1. RxList: PhosLo (Calcium Acetate Tablet): Side Effects, Uses, Dosage, Overdose, Pregnancy, Alcohol.
2. Research Nester: Calcium Phosphate Market Size, Growth Analysis 2025-2037.
3. Unicycive Therapeutics: Unicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC).
4. FDA: PhosLo (calcium acetate) - accessdata.fda.gov.
5. GMI Insights: Phosphate Salts Market Size, Share, Trends & Forecasts – 2034.

Last updated: 2025-01-03