In short
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.
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
- 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
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. 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. 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.
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. 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)
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.
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.
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.