CLINICAL TRIALS PROFILE FOR CALCIUM ACETATE

505(b)(2) Clinical Trials for CALCIUM ACETATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT04039828 ↗	Zinc Sulfate Acceptability	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	N/A	2019-09-09	Introduction: Zinc (Zn) is an essential mineral widely distributed within the human body with metalloproteins, Zinc-binding proteins, etc. It is necessary for signal transduction and also cell growth and proliferation via respective metallo- and zinc-dependent enzymes. Zinc supplementation can significantly reduce diarrheal severity and duration as well as prevents future incidences and reduces use of other medications in diarrhoea. For this reason WHO, UNICEF, USAID and experts worldwide jointly recommended zinc supplementation (10 mg for infants less than 6 months old and 20 mg in 6 - 59 months old) combined with reduced osmolarity ORS for clinical management of acute diarrhoea. But due to strong metallic taste zinc products are less palatable to children even after using masking flavours as recommended by WHO. Several companies have formulated the product since WHO recommendations came but still transient side effects like vomiting and regurgitation remain evident. Despite careful counselling to the caregivers expected adherence rate to 10 days regimen of zinc supplement is yet to be reached. With the aim to increase zinc supplement coverage during acute diarrheal illness, it is necessary to conduct a study to introduce new formulation Zinc tablet which is more palatable, more dispersible and more acceptable. Intervention: Zinc sulfate [Zinc Dispersible Tablet, 20 mg; (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)] Methods: Prospective, open label, interventional study Hypothesis: Improved formulation of Zinc Sulfate will have good acceptability. Study population: Stratum 1: 3 months - <18 months = 175 children Stratum 2: 18 months - 59 months = 175 children Objectives: 1. Primary Objective: Acceptability of the zinc product in the management of childhood diarrhea will be assessed by observing: i) Incidence of vomiting or regurgitation among enrolled children receiving the improvised zinc formulation. ii) The adherence: The number of days (out of the total 10 days) the child took the protocol-prescribed dose of the medicine. The treatment will be considered to have good acceptability if at least 80% of the prescribed treatment is taken by at least 70% of the children over the duration of 10 days, as per WHO guidelines. 2. Secondary objective : To assess palatability Secondary end point evaluation (Palatability): The statistical analysis will comprise the calculation of the percentage of patients out of 350 who found the investigational product to have "very well-tolerated, well-tolerated or tolerated" scores (i.e. any of the upper 3 possible scores). A 95% confidence interval, using the normal approximation of the binomial distribution, will be calculated for the percentage.

All Clinical Trials for CALCIUM ACETATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00114114 ↗	Dose-Response of Gonadal Steroids and Bone Turnover in Older Men	Completed	AbbVie	N/A	2004-09-01	The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.
NCT00114114 ↗	Dose-Response of Gonadal Steroids and Bone Turnover in Older Men	Completed	AstraZeneca	N/A	2004-09-01	The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.
NCT00114114 ↗	Dose-Response of Gonadal Steroids and Bone Turnover in Older Men	Completed	National Institute on Aging (NIA)	N/A	2004-09-01	The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.
NCT00018135 ↗	Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals	Completed	National Center for Research Resources (NCRR)	N/A	1969-12-31	Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the blood and a secondary increase in the iPTH level. This chronic elevation in iPTH can have adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease the absorption of phosphorus present in the normal diet. Some preliminary studies have indicated that the iPTH level may change based on the amount of phosphorus present in a meal prior to any significant absorption of phosphorus. If this is true in hemodialysis patients, then the timing of the administration of phosphate binders in relation to the ingestion of meals needs to be considered

Clinical Trial Conditions for CALCIUM ACETATE

Condition Name

Condition Name for CALCIUM ACETATE
Intervention	Trials
Hyperphosphatemia	8
Chronic Kidney Disease	5
Calcinosis	2
Healthy Volunteers	2

Condition MeSH

Condition MeSH for CALCIUM ACETATE
Intervention	Trials
Kidney Diseases	12
Renal Insufficiency, Chronic	10
Hyperphosphatemia	9
Hyperparathyroidism	3

Clinical Trial Locations for CALCIUM ACETATE

Trials by Country

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−

Trials by Country for CALCIUM ACETATE
Location	Trials
United States	63
China	3
Romania	2
Bangladesh	2
Italy	2

Trials by US State

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−

Trials by US State for CALCIUM ACETATE
Location	Trials
Texas	5
New York	5
Pennsylvania	4
Ohio	3
Michigan	3

Clinical Trial Progress for CALCIUM ACETATE

Clinical Trial Phase

Clinical Trial Phase for CALCIUM ACETATE
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	8
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for CALCIUM ACETATE
Clinical Trial Phase	Trials
Completed	28
Unknown status	5
Recruiting	3

Clinical Trial Sponsors for CALCIUM ACETATE

Sponsor Name

Sponsor Name for CALCIUM ACETATE
Sponsor	Trials
Shire	4
International Centre for Diarrhoeal Disease Research, Bangladesh	3
Genzyme, a Sanofi Company	3

Sponsor Type

Sponsor Type for CALCIUM ACETATE
Sponsor	Trials
Other	36
Industry	26
NIH	2

Calcium Acetate: Clinical Trials, Market Analysis, and Projections

Introduction to Calcium Acetate

Calcium acetate is a versatile chemical compound with diverse applications, including pharmaceuticals, food and beverage, and various industrial sectors. In the pharmaceutical industry, it is primarily used to treat hyperphosphatemia in patients with end-stage renal disease (ESRD) who are undergoing dialysis.

Clinical Trials and Efficacy

Hyperphosphatemia Management

Clinical trials have demonstrated the efficacy of calcium acetate in managing hyperphosphatemia. A notable study involved 91 patients with ESRD who were undergoing hemodialysis and had serum phosphorus levels greater than 5.5 mg/dL. These patients received calcium acetate tablets at each meal, with the dose adjusted to control serum phosphorus levels. After 12 weeks, the study showed a significant decrease in serum phosphorus levels, highlighting the effectiveness of calcium acetate in this context[4].

Comparison with Sevelamer

A randomized, controlled trial compared the effects of calcium acetate and sevelamer on the progression of coronary artery calcification (CAC) in hemodialysis patients. The study found that both groups had similar geometric mean increases in CAC scores, suggesting that intensive lowering of LDL-C levels with atorvastatin in patients treated with calcium acetate resulted in CAC progression rates similar to those in sevelamer-treated patients[1].

Safety and Tolerability

Clinical studies have generally shown that calcium acetate is well tolerated. A 3-month, open-label, non-randomized study and a two-week double-blind, placebo-controlled, cross-over study involving ESRD hemodialysis patients reported adverse reactions, but these were not significantly different from those in the placebo group. The most common adverse reactions included hypercalcemia, which is discussed in the warnings and precautions section[4].

Market Analysis

Global Market Size and Growth

The global calcium acetate market is projected to experience substantial growth over the coming years. According to market forecasts, the calcium acetate market is expected to reach $132.4 million by 2030, growing at a CAGR of 3.20% during the forecast period 2024-2030[5].

Regional Outlook

The Asia-Pacific region dominates the calcium acetate market, driven by the growth of the pharmaceutical industry. Countries like Vietnam, Indonesia, and Malaysia are seeing significant increases in pharmaceutical production, which in turn boosts the demand for calcium acetate. In contrast, developed economies in North America and Europe are expected to witness sluggish growth due to market saturation[2][5].

End-Use Industries

Pharmaceutical Industry

The pharmaceutical segment holds the largest share of the calcium acetate market. Calcium acetate is crucial for treating hyperphosphatemia in patients with ESRD, and the increasing cases of end-stage renal disease are driving the demand for this medication. For instance, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the number of Americans living with ESRD is on the rise, contributing to the growing demand for calcium acetate[5].

Food and Beverage Industry

Calcium acetate is widely used in the food and beverage industry as a preservative to enhance the shelf life of products such as bakery items, processed meats, and other food products. The growth of the bakery industry, particularly in Canada and Southeast Asian countries, is a significant factor driving the demand for calcium acetate in this sector[2][3].

Other Industries

Besides pharmaceuticals and food, calcium acetate is used in various other industries, including wastewater treatment, construction, and chemicals. Its applications as a texturizer, thickener, stabilizer, and firming agent make it a versatile compound with a broad range of uses[3].

Market Projections

Growth Drivers

• Increasing Demand from Pharmaceutical Industry: The rising number of patients with ESRD and the growing need for effective treatments for hyperphosphatemia are key drivers for the calcium acetate market.
• Expansion in Food and Beverage Industry: The increasing demand for preservatives to extend the shelf life of food products, especially in the bakery sector, is another significant driver.
• Industrial Applications: Growing industrialization and the need for calcium acetate in various industrial processes, such as wastewater treatment and construction, are also driving market growth[2][3][5].

Challenges and Limitations

• Availability of Substitutes: The presence of substitutes like calcium carbonate and other phosphate binders could restrict market growth.
• Market Saturation: In developed economies, market saturation is expected to slow down the growth of the calcium acetate market[2][5].

Key Takeaways

• Clinical Efficacy: Calcium acetate is effective in managing hyperphosphatemia in ESRD patients and has comparable outcomes to sevelamer in terms of CAC progression.
• Market Growth: The global calcium acetate market is projected to grow significantly, driven by the pharmaceutical and food and beverage industries.
• Regional Variations: Asia-Pacific regions are expected to dominate the market, while North America and Europe will experience slower growth due to market saturation.
• Diverse Applications: Calcium acetate has a broad range of applications beyond pharmaceuticals, including food preservation and industrial uses.

FAQs

What is the primary use of calcium acetate in the pharmaceutical industry?

Calcium acetate is primarily used to treat hyperphosphatemia in patients with end-stage renal disease (ESRD) who are undergoing dialysis.

How does calcium acetate compare to sevelamer in clinical trials?

Clinical trials have shown that calcium acetate and sevelamer have similar effects on the progression of coronary artery calcification (CAC) in hemodialysis patients, especially when combined with intensive LDL-C lowering with atorvastatin[1].

What are the main drivers of the calcium acetate market?

The main drivers include increasing demand from the pharmaceutical industry for treating hyperphosphatemia, growth in the food and beverage industry for preservative uses, and expanding industrial applications.

What are the potential challenges for the calcium acetate market?

The availability of substitutes like calcium carbonate and market saturation in developed economies are potential challenges that could restrict market growth.

In which regions is the calcium acetate market expected to grow the most?

The Asia-Pacific region is expected to dominate the market due to the growth of the pharmaceutical and food and beverage industries in countries like Vietnam, Indonesia, and Malaysia.

Sources

1. A 1-year randomized trial of calcium acetate versus sevelamer on progression of coronary artery calcification in hemodialysis patients with comparable lipid profiles. PubMed.
2. Calcium Acetate Market Size, Share & Trends Analysis Report By Application, Regional Outlook, Competitive Strategies, And Segment Forecasts, 2019 To 2025. Grand View Research.
3. Calcium Acetate Market Report to 2031. Visiongain.
4. Calcium Acetate Capsules: Package Insert / Prescribing Info. Drugs.com.
5. Calcium Acetate Market Size, Share | Industry Trend & Forecast 2030. IndustryARC.