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Keto-Valine Calcium

This article discusses the clinical trials investigating the use of Keto-Valine Calcium, a component of the drug Ketosteril, in preventing muscle loss in patients with nephrotic syndrome. The trials aim to assess 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-VALINE CALCIUM?

KETO-VALINE 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 drug called KETOSTERIL, which is being studied for its potential benefits in treating muscle loss in patients with kidney problems[1]. This compound is also known by its chemical name, hemicalcium 3-methyl-2-oxobutyrate[1].

Clinical Trial Overview

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

Target Condition: Protein-Energy Wasting in Nephrotic Syndrome

The trial focuses on a condition called protein-energy wasting in nephrotic syndrome. 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. Protein-energy wasting refers to the loss of body protein mass and fuel reserves[1].

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key inclusion criteria are:

  • Having nephrotic syndrome with low blood albumin levels and high protein in urine
  • Being at least 18 years old
  • Having kidney function above a certain level

Some exclusion criteria include:

  • Having certain other medical conditions like diabetes-related kidney disease or cancer
  • Being very overweight (BMI of 40 or higher)
  • Having had a kidney transplant

These criteria help ensure that the study focuses on the right group of patients and that it’s safe for those who participate[1].

Study Objectives

The main goal of this study is to see if KETO-VALINE CALCIUM and other ketoanalogues can help prevent muscle loss in people with nephrotic syndrome. The researchers also want to understand:

  • How the treatment affects the progression of kidney disease
  • Its impact on metabolism and heart health
  • How it affects patients’ quality of life

These objectives will help doctors understand if this treatment could be a valuable option for patients with nephrotic syndrome[1].

Endpoints: Measuring the Drug’s Effectiveness

To determine if the treatment is working, researchers will look at several factors, including:

  1. The maximum loss of lean body mass over 6 months
  2. Changes in muscle strength (measured by handgrip strength)
  3. Changes in physical endurance (measured by a 6-minute walk test)
  4. Changes in blood protein levels
  5. Changes in kidney function and protein in urine

These measurements will help determine if KETO-VALINE CALCIUM and other ketoanalogues are effective in preventing muscle loss and improving overall health in patients with nephrotic syndrome[1].

Potential Benefits

If successful, this treatment could offer several benefits to patients with nephrotic syndrome:

  • Prevention of muscle loss, which is crucial for maintaining strength and overall health
  • Potential improvement in kidney function
  • Better metabolic health, including improvements in cholesterol and triglyceride levels
  • Enhanced quality of life

However, it’s important to remember that these potential benefits are still being studied, and more research is needed to confirm the effectiveness and safety of this treatment[1].

Aspect Details
Study Name FORMA – Multicentre randomized-controlled trial
Main Objective Evaluate efficacy and safety of ketoanalogues in preventing muscle loss in nephrotic syndrome
Medication Ketosteril (containing Keto-Valine Calcium)
Form Film-coated tablets
Duration 6 months
Primary Outcome Maximum loss of lean body mass
Key Inclusion Criteria Age ≥18, nephrotic syndrome, specific protein and albumin levels
Key Exclusion Criteria Secondary conditions, recent clinical trial participation, BMI ≥40 kg/m2

FAQ

  • What is the main purpose of the clinical trial using Keto-Valine Calcium? The main purpose of the clinical trial is to evaluate the effectiveness, safety, and tolerability of Keto-Valine Calcium (as part of Ketosteril) in preventing muscle loss, also known as protein-energy wasting, 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 are the main outcomes being measured in this trial? The primary outcome is the maximum loss of lean body mass within 6 months of starting the study. Secondary outcomes include changes in lean tissue mass, diagnosis of protein-energy wasting, performance in a 6-minute walk test, handgrip strength, and various blood and urine markers.
  • How long does the clinical trial last? The clinical trial lasts for 6 months, during which various measurements and tests are performed to assess the effectiveness of the treatment.
  • What form does the medication come in? The medication, Ketosteril, which contains Keto-Valine Calcium, comes in the form of film-coated tablets that are taken orally.

Ongoing Clinical Trials on Keto-Valine Calcium

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

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

    Not yet recruiting

    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 fat stores in patients with chronic kidney disease, often leading to muscle loss and weakness.
  • Glomerular filtration rate: A measure of how well the kidneys are filtering waste from the blood, used to determine kidney function.
  • Lean body mass: The weight of all body tissues except fat, including muscles, bones, and organs.
  • Ketoanalogues: Modified forms of essential amino acids that can be converted to the original amino acids in the body, often used to provide protein nutrition while reducing nitrogen intake in kidney patients.
  • Albumin: A protein made by the liver that helps maintain fluid balance in the body and transport various substances in the blood.
  • Proteinuria: The presence of excess proteins in the urine, often a sign of kidney disease.
  • 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.

References

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