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Keto-Leucine Calcium

This article discusses a clinical trial investigating the use of Keto-Leucine Calcium, a component of the drug Ketosteril, in preventing muscle loss in patients with nephrotic syndrome. The study aims to evaluate the efficacy, safety, and tolerability of this treatment in a new clinical indication, focusing on its potential to prevent protein-energy wasting in individuals with moderate to severe nephrotic syndrome.

Table of Contents

What is KETO-LEUCINE CALCIUM?

KETO-LEUCINE 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 currently being studied for its potential benefits in preventing muscle loss in patients with a condition called nephrotic syndrome.

Medical Conditions Treated

The primary medical condition being targeted in this study is protein-energy wasting in nephrotic syndrome[1]. Nephrotic syndrome is a kidney disorder that causes your body to excrete too much protein in your urine. This can lead to a range of problems, including muscle loss and malnutrition.

How It Works

KETO-LEUCINE CALCIUM and other ketoanalogues work by providing the body with alternatives to essential amino acids. When you have kidney problems, your body might struggle to process certain proteins effectively. These ketoanalogues can be converted into essential amino acids in the body without producing as much waste that the kidneys need to filter out[1].

Clinical Trial Details

A clinical trial called FORMA is currently underway to evaluate the effectiveness and safety of ketoanalogues of essential amino acids (including KETO-LEUCINE CALCIUM) in preventing muscle loss in patients with nephrotic syndrome[1]. This is a Phase 3 trial, which means it’s in an advanced stage of testing.

Potential Benefits

The researchers are hoping to see several potential benefits from this treatment:

  • Prevention of muscle loss (measured by changes in lean body mass)
  • Improvement in physical function (measured by a 6-minute walk test and handgrip strength)
  • Better control of nephrotic syndrome symptoms (measured by changes in serum albumin and protein in urine)
  • Improvements in metabolic health (measured by changes in cholesterol and triglyceride levels)[1]

Who Can Receive This Treatment?

In the clinical trial, the treatment is being tested on adults (18 years or older) who have moderate to severe nephrotic syndrome. Participants need to have low levels of albumin in their blood and high levels of protein in their urine. The trial excludes people with certain other health conditions, such as diabetes-related kidney disease or active cancer[1].

Administration and Dosage

KETOSTERIL, which contains KETO-LEUCINE CALCIUM, is given as a film-coated tablet that is taken by mouth. In the clinical trial, the maximum daily dose is 15.12 grams. The treatment period in the trial lasts for up to 12 months[1].

It’s important to note that this treatment is still being studied, and it’s not yet approved for general use in patients with nephrotic syndrome. If you have nephrotic syndrome and are interested in this treatment, you should discuss it with your doctor to see if participating in a clinical trial might be appropriate for you.

Aspect Details
Study Name FORMA – Multicentre randomized-controlled trial
Main Objective Evaluate efficacy and safety of ketoanalogues in preventing muscle loss in nephrotic syndrome
Primary Endpoint Maximum loss of lean body mass within 6 months
Key Inclusion Criteria Nephrotic syndrome, age ≥18, specific protein and albumin levels
Key Exclusion Criteria Secondary nephrotic syndrome, recent clinical trial participation, BMI ≥40 kg/m2
Treatment Duration 6 months
Secondary Outcomes Changes in lean tissue mass, 6-minute walk test, handgrip strength, serum albumin, uPCR, lipid profile

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 Keto-Leucine Calcium (a component of Ketosteril) in preventing muscle loss in patients with moderate to 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 is the primary outcome being measured in this study? The primary outcome being measured is the maximum loss of lean body mass from the initial value within 6 months of study inclusion.
  • How long does the clinical trial last? The clinical trial lasts for 6 months, during which various measurements and tests are conducted to assess the effectiveness of the treatment.
  • What other factors are being evaluated in this study? The study also evaluates the impact of the treatment on the clinical course of glomerular disease, metabolic profile, renal function, and early biomarkers of vascular endothelial damage. Additionally, it assesses patients' quality of life and their adherence to the treatment recommendations.

Ongoing Clinical Trials on Keto-Leucine 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 characterized by high levels of protein in the urine, low levels of protein in the blood, and swelling in various parts of the body.
  • Protein-energy wasting: A condition of decreased body protein and energy stores in patients with chronic kidney disease.
  • Keto-Leucine Calcium: A component of the drug Ketosteril, which is being studied for its potential to prevent muscle loss in nephrotic syndrome patients.
  • Glomerular filtration rate: A measure of how well the kidneys are filtering waste from the blood.
  • Lean body mass: The weight of your body minus the weight of your body fat, primarily consisting of muscles, bones, and organs.
  • Immunosuppressive treatment: Medications that suppress the immune system, often used to treat autoimmune diseases or prevent organ rejection after transplantation.
  • Biomarkers: Measurable indicators in the body that can be used to assess the presence or progress of a disease or the effects of a treatment.
  • Handgrip strength: A measure of muscular strength that is often used as an indicator of overall physical health and muscle function.
  • Urine 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.

References

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