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Keto-Isoleucine Calcium

This article discusses a clinical trial investigating the use of Keto-Isoleucine Calcium, a component of the drug Ketosteril, in preventing muscle loss in patients with nephrotic syndrome. The study aims to assess the efficacy and safety of ketoanalogues of essential amino acids in protecting against protein-energy wasting, a common complication in nephrotic syndrome patients.

Table of Contents

What is KETO-ISOLEUCINE CALCIUM?

KETO-ISOLEUCINE CALCIUM is a medical compound that belongs to a group of substances called ketoanalogues of essential amino acids. It is one of the active ingredients in a medication called KETOSTERIL[1]. This medication is being studied for its potential to prevent muscle loss in patients with a condition called nephrotic syndrome.

KETO-ISOLEUCINE CALCIUM is also known by other names, including:

  • (3S)-3-Methyl-2-oxopentanoic acid hemicalcium
  • Alpha-keto-isoleucine calcium
These alternative names might be used in scientific literature or by healthcare professionals[1].

Medical Condition Targeted

The main medical condition that KETO-ISOLEUCINE CALCIUM is being studied for is protein-energy wasting in nephrotic syndrome[1]. Let’s break down what this means:

  • Nephrotic syndrome is a kidney disorder that causes your body to excrete too much protein in your urine.
  • Protein-energy wasting is a condition where the body loses muscle mass and fat tissue, often due to chronic diseases like kidney problems.

This condition can lead to significant muscle loss, weakness, and other health problems. The research is focusing on whether KETO-ISOLEUCINE CALCIUM and other similar compounds can help prevent this muscle loss in patients with nephrotic syndrome[1].

How It Works

KETO-ISOLEUCINE CALCIUM is a ketoanalogue of the essential amino acid isoleucine. Here’s a simple explanation of how it’s thought to work:

  1. When you have kidney problems, your body might not process proteins well, leading to muscle loss.
  2. KETO-ISOLEUCINE CALCIUM and other ketoanalogues can be converted into essential amino acids in your body.
  3. These compounds provide the benefits of protein without putting extra stress on your kidneys.
  4. By doing this, they may help prevent muscle loss and maintain your body’s protein balance[1].

Clinical Trial Details

A clinical trial called FORMA is currently studying KETO-ISOLEUCINE CALCIUM along with other ketoanalogues. Here are some key details about the trial:

  • It’s a Phase 3 clinical trial, which means it’s in an advanced stage of testing[1].
  • The trial aims to evaluate the efficacy, safety, and tolerability of these compounds for preventing muscle loss in patients with moderate to very severe nephrotic syndrome[1].
  • It’s a multicentre randomized-controlled trial, meaning it’s being conducted at multiple hospitals or medical centers, and patients are randomly assigned to different treatment groups[1].

Eligibility Criteria

To participate in this study, patients need to meet certain criteria. Here are some of the main requirements:

  • Have nephrotic syndrome with specific levels of serum albumin and proteinuria[1].
  • Be at least 18 years old[1].
  • Have a certain level of kidney function[1].

There are also conditions that would exclude someone from participating, such as:

  • Having certain other medical conditions[1].
  • Recent participation in other clinical trials[1].
  • Having had a kidney transplant[1].

Potential Benefits

While the full benefits are still being studied, researchers hope that KETO-ISOLEUCINE CALCIUM and related compounds might:

  • Prevent or reduce muscle loss in patients with nephrotic syndrome[1].
  • Improve physical function, such as walking distance and grip strength[1].
  • Positively affect various health markers, including serum albumin levels and cholesterol levels[1].
  • Potentially improve the overall quality of life for patients with this condition[1].

Side Effects and Safety

As this is an ongoing clinical trial, the full safety profile of KETO-ISOLEUCINE CALCIUM for this specific use is not yet known. The study is designed to evaluate the safety and tolerability of the treatment[1].

It’s important to note that this treatment is still being researched and is not yet approved for general use in treating nephrotic syndrome. Patients should always consult with their healthcare providers about their treatment options and any potential risks or side effects.

Aspect Details
Study Name FORMA – Multicentre randomized-controlled trial
Main Objective Evaluate efficacy and safety of ketoanalogues in preventing muscle loss in nephrotic syndrome
Drug Studied Ketosteril (containing Keto-Isoleucine Calcium and other ketoanalogues)
Primary Endpoint Maximum loss of lean body mass within 6 months
Key Inclusion Criteria Age ≥18, nephrotic syndrome, specific protein and albumin levels
Key Exclusion Criteria Secondary nephrotic syndrome, recent clinical trial participation, BMI ≥40 kg/m2
Secondary Measurements Lean tissue mass, walking test, handgrip strength, blood markers
Study Duration 6 months for primary outcomes

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the effectiveness, safety, and tolerability of ketoanalogues of essential amino acids (including Keto-Isoleucine Calcium) in preventing muscle loss in patients with moderate to very severe nephrotic syndrome.
  • Who can participate in this clinical trial? Participants must be at least 18 years old, have nephrotic syndrome with specific protein and albumin levels, and have a glomerular filtration rate of 30 mL/min/1.73m2 or higher. They should not have certain secondary conditions, recent participation in other clinical trials, or a body mass index of 40 kg/m2 or greater.
  • What will be measured during the trial? The trial will measure changes in lean body mass, lean tissue mass, walking distance in a 6-minute test, handgrip strength, serum albumin levels, urinary protein levels, and various blood markers such as LDL cholesterol, triglycerides, and uric acid.
  • How long does the trial last? The main outcomes of the trial will be measured over a 6-month period.
  • What is Ketosteril and how is it related to Keto-Isoleucine Calcium? Ketosteril is the brand name of the drug being studied, which contains multiple active ingredients including Keto-Isoleucine Calcium. It is a film-coated tablet that contains ketoanalogues of essential amino acids and is designed to help prevent muscle loss in patients with kidney problems.

Ongoing Clinical Trials on Keto-Isoleucine Calcium

  • Study on Ketoanalogue Supplementation for Muscle Protection in Patients with Stage 4 and 5 Chronic Kidney Disease on a Low Protein Diet

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness of Ketoanalogues in Preventing Muscle Loss in Patients with Nephrotic Syndrome

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Ketosteril Added to Usual Nutrition for Patients Starting Incremental Haemodialysis with Incremental Haemodialysis

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Nephrotic syndrome: A kidney disorder that causes your body to excrete too much protein in your urine, often resulting in swelling and other complications.
  • Protein-energy wasting: A condition of decreased body protein and fat stores in patients with chronic diseases, often leading to muscle loss and weakness.
  • Ketoanalogues: Modified forms of essential amino acids that can be converted to standard amino acids in the body, often used to provide protein nutrition with less nitrogen waste.
  • Glomerular filtration rate: A measure of how well your kidneys are working, specifically how much blood passes through the glomeruli (tiny filters in the kidneys) each minute.
  • Lean body mass: The weight of your body minus all the fat tissue, primarily consisting of muscle, bones, and organs.
  • Serum albumin: A protein made by the liver that circulates in the blood and helps maintain fluid balance in the body.
  • Urinary protein-to-creatinine ratio (uPCR): A test that measures the amount of protein in the urine relative to creatinine, used to assess kidney function and protein loss.
  • LDL cholesterol: Low-density lipoprotein cholesterol, often called 'bad' cholesterol, which can contribute to the buildup of plaque in arteries.
  • Triglycerides: A type of fat in the blood that can contribute to heart disease when levels are too high.
  • Uric acid: A waste product formed from the breakdown of certain foods and body tissues, which can cause problems when levels are too high.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-ketoanalogues-in-preventing-muscle-loss-in-patients-with-nephrotic-syndrome/