In short
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.
At a glance
- 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
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. 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.
Medical Condition Targeted
The main medical condition that KETO-ISOLEUCINE CALCIUM is being studied for is protein-energy wasting in nephrotic syndrome. 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.
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:
- When you have kidney problems, your body might not process proteins well, leading to muscle loss.
- KETO-ISOLEUCINE CALCIUM and other ketoanalogues can be converted into essential amino acids in your body.
- These compounds provide the benefits of protein without putting extra stress on your kidneys.
- By doing this, they may help prevent muscle loss and maintain your body's protein balance.
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.
- 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.
- 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.
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.
- Be at least 18 years old.
- Have a certain level of kidney function.
There are also conditions that would exclude someone from participating, such as:
- Having certain other medical conditions.
- Recent participation in other clinical trials.
- Having had a kidney transplant.
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.
- Improve physical function, such as walking distance and grip strength.
- Positively affect various health markers, including serum albumin levels and cholesterol levels.
- Potentially improve the overall quality of life for patients with this condition.
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.
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.