CLINICAL TRIALS PROFILE FOR AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

505(b)(2) Clinical Trials for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride

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	NCT01889173 ↗	Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2013-06-01	Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).

All Clinical Trials for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004284 ↗	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284 ↗	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	University of Texas	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284 ↗	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	National Center for Research Resources (NCRR)	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00120731 ↗	Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones	Withdrawn	Children's Mercy Hospital Kansas City	N/A	2005-07-01	High amounts of calcium in the urine (hypercalciuria) can cause development of kidney stones in children. Treatment for these children includes plenty of fluids, a low-salt diet and medications such as potassium citrate. A major advantage of potassium citrate, as compared to hydrochlorothiazide, is its lack of side effects. One problem the researchers and others have observed is that some children continue to form kidney stones despite correction of hypercalciuria with potassium citrate. One possible explanation is that in some individuals potassium citrate therapy results in an excessive elevation of urine pH, a situation that may predispose to calcium phosphate stone formation. In this study, the researchers will study the effects of potassium citrate on urine chemistries and acid-base balance in three groups of children aged 5-17 years: - children who are hypercalciuric stone formers; - healthy children without a history of hypercalciuria or kidney stones. Particular attention will be paid to try to identify those who develop a very high urine pH (>8) and the factors leading to this metabolic reaction. The researchers will try to learn whether it is the child's characteristics, the disease manifestations, the dose of the drug, or a combination of the above which may be the cause of the development of very alkaline urine. Based on the results, the researchers hope to be able to better "tailor" the individual treatment for each child with kidney stones.
NCT00291720 ↗	Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?	Completed	British Heart Foundation	Phase 2	2005-04-01	Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels. The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure

Clinical Trial Conditions for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride

Condition Name

Condition Name for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Intervention	Trials
Healthy	3
Respiratory Distress Syndrome, Adult	2
Colon Cancer	2
Nephrolithiasis	2

Condition MeSH

Condition MeSH for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Intervention	Trials
Nephrolithiasis	6
Kidney Calculi	6
Hypercalciuria	3
Calculi	3

Clinical Trial Locations for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride

Trials by Country

Trials by Country for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Location	Trials
United States	29
Canada	3
Switzerland	3
Egypt	3
United Kingdom	3

Trials by US State

Trials by US State for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Location	Trials
Maryland	3
California	3
Minnesota	3
Illinois	2
Texas	2

Clinical Trial Progress for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	4
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Clinical Trial Phase	Trials
Completed	23
Not yet recruiting	7
Terminated	5

Clinical Trial Sponsors for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride

Sponsor Name

Sponsor Name for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Sponsor	Trials
University of Minnesota	3
Rigshospitalet, Denmark	2
National Institute of General Medical Sciences (NIGMS)	2

Sponsor Type

Sponsor Type for Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride
Sponsor	Trials
Other	64
Industry	9
NIH	8

CLINIMIX and CLINIMIX E: Comprehensive Overview, Clinical Trials, and Market Analysis

Introduction

CLINIMIX and CLINIMIX E are intravenous nutrition solutions developed by Baxter Healthcare Corporation, designed to provide essential nutrients for patients who cannot receive nutrition through oral or enteral means. These solutions are crucial in clinical settings, particularly for patients with severe nutritional deficiencies or those undergoing significant medical treatments.

Indications and Usage

CLINIMIX and CLINIMIX E are indicated as sources of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. They are used to treat negative nitrogen balance and provide necessary nutrients to stabilize patients[3][4].

CLINIMIX

CLINIMIX contains amino acids in dextrose and is available in various concentrations, such as 4.25% amino acids in 5% dextrose, 4.25% amino acids in 10% dextrose, and others. It is used to provide protein and calories but does not contain added electrolytes[2].

CLINIMIX E

CLINIMIX E includes amino acids with electrolytes in dextrose with calcium, making it a more comprehensive nutritional solution. It is available in several formulations, including 5% amino acids with electrolytes in 10% dextrose, 5% amino acids with electrolytes in 15% dextrose, and others. This formulation is particularly useful for patients requiring both protein and electrolytes[3][4].

Composition

Amino Acids

Both CLINIMIX and CLINIMIX E contain essential and nonessential amino acids necessary for protein synthesis. The amino acid composition includes leucine, isoleucine, valine, lysine, phenylalanine, histidine, threonine, methionine, and tryptophan[2][4].

Dextrose

Dextrose serves as a source of calories in both formulations. The concentration of dextrose varies, ranging from 5% to 20% in different formulations[2][4].

Electrolytes

CLINIMIX E includes electrolytes such as calcium chloride, magnesium chloride, potassium phosphate, dibasic, sodium acetate, and sodium chloride, which are essential for maintaining electrolyte balance[3][4].

Clinical Trials and Safety

Pulmonary Embolism Risk

One of the significant risks associated with parenteral nutrition, including CLINIMIX and CLINIMIX E, is the risk of pulmonary vascular precipitates causing pulmonary embolism. This risk is highlighted in the prescribing information, and careful monitoring is recommended[2].

Contraindications

Both CLINIMIX and CLINIMIX E are contraindicated in patients with known hypersensitivity to amino acids or dextrose, those with inborn errors of amino acid metabolism, and those with pulmonary edema or acidosis due to low cardiac output. Additionally, CLINIMIX E is contraindicated in neonates receiving concomitant treatment with ceftriaxone[2][3].

Pediatric and Geriatric Use

There have been no adequate and well-controlled studies on the safety and effectiveness of CLINIMIX in pediatric patients. For geriatric patients, dose selection should be cautious due to the potential for decreased hepatic, renal, or cardiac function[2][4].

Market Analysis

Market Presence

CLINIMIX and CLINIMIX E have been widely adopted in hospitals and clinical settings globally. Baxter Healthcare Corporation provides extensive support for the implementation of these products, including product education, inservicing, and tools to help pharmacies manage the conversion process[1].

Market Trends

The demand for parenteral nutrition solutions is increasing due to the growing number of patients requiring intensive care and those with complex nutritional needs. The market is driven by advancements in healthcare technology, an aging population, and the need for personalized nutrition therapy.

Competitive Landscape

The parenteral nutrition market is competitive, with several other companies offering similar products. However, CLINIMIX and CLINIMIX E remain prominent due to their comprehensive formulations and the extensive support provided by Baxter Healthcare Corporation.

Projections

Future Growth

The market for parenteral nutrition solutions is expected to grow significantly over the next few years, driven by increasing healthcare expenditures and the need for advanced nutritional therapies. CLINIMIX and CLINIMIX E are likely to remain key players in this market due to their established presence and continuous innovation.

Regulatory Environment

Regulatory approvals and compliance are crucial for the continued success of CLINIMIX and CLINIMIX E. The products have been approved in several countries, including the US, since 1997, and ongoing regulatory updates ensure they meet the latest safety and efficacy standards[5].

Clinical Best Practices

Dosage and Administration

The dosage selection for CLINIMIX and CLINIMIX E is based on the recommended protein requirements, with consideration of the maximum dextrose infusion rates and calorie and fluid requirements. The administration rate should be governed by the patient’s tolerance to dextrose, especially during the initial days of therapy[3].

Monitoring and Adjustments

Patients receiving CLINIMIX or CLINIMIX E should be monitored for fluid, electrolyte, and acid-base disorders. Additional nutrients such as vitamins, trace elements, and lipids may need to be administered to prevent deficiencies and complications[3][4].

Key Takeaways

• Indications: CLINIMIX and CLINIMIX E are used for patients requiring parenteral nutrition when oral or enteral nutrition is not possible.
• Composition: Both contain amino acids and dextrose; CLINIMIX E also includes electrolytes.
• Safety: Risks include pulmonary embolism, and contraindications include hypersensitivity to amino acids or dextrose.
• Market Analysis: The products are widely adopted, with a growing market driven by healthcare advancements and increasing demand for personalized nutrition.
• Projections: Expected growth in the parenteral nutrition market, with CLINIMIX and CLINIMIX E remaining key players.

FAQs

What are the primary indications for CLINIMIX and CLINIMIX E?

CLINIMIX and CLINIMIX E are indicated as sources of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

What are the key components of CLINIMIX and CLINIMIX E?

CLINIMIX contains amino acids in dextrose, while CLINIMIX E includes amino acids with electrolytes in dextrose with calcium.

What are the contraindications for CLINIMIX and CLINIMIX E?

Both are contraindicated in patients with known hypersensitivity to amino acids or dextrose, those with inborn errors of amino acid metabolism, and those with pulmonary edema or acidosis due to low cardiac output. CLINIMIX E is also contraindicated in neonates receiving concomitant treatment with ceftriaxone.

How should CLINIMIX and CLINIMIX E be administered?

The dosage selection is based on recommended protein requirements, with consideration of maximum dextrose infusion rates and calorie and fluid requirements. Patients should be monitored for fluid, electrolyte, and acid-base disorders.

What are the potential risks associated with CLINIMIX and CLINIMIX E?

One of the significant risks is the potential for pulmonary vascular precipitates causing pulmonary embolism. Other risks include metabolic complications such as acid-base and electrolyte imbalances.

Are there any specific considerations for pediatric and geriatric patients?

There have been no adequate and well-controlled studies on the safety and effectiveness of CLINIMIX in pediatric patients. For geriatric patients, dose selection should be cautious due to potential decreased hepatic, renal, or cardiac function.

Sources

1. Baxter Healthcare Corporation. CLINIMIX and CLINIMIX E Portfolio Brochure.
2. FDA. CLINIMIX (amino acids in dextrose) injection, for intravenous use.
3. Drugs.com. CLINIMIX E: Package Insert / Prescribing Information.
4. Health Canada. CLINIMIX E / CLINIMIX products.
5. Patsnap Synapse. Amino acids/Calcium chloride/Dextrose/Magnesium chloride/Potassium phosphate, dibasic/Sodium acetate/Sodium chloride.

Last updated: 2025-01-03