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

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What is this study about?

This clinical trial is focused on studying a condition known as nephrotic syndrome, which can lead to a problem called protein-energy wasting. This condition involves the loss of muscle and energy stores in the body. The study is testing a treatment called KETOSTERIL, which is a type of medication that contains special forms of essential amino acids. These amino acids are important building blocks for proteins in the body and may help prevent muscle loss in people with nephrotic syndrome.

The purpose of the study is to evaluate how effective and safe KETOSTERIL is in preventing muscle loss in patients with moderate to very severe nephrotic syndrome. Participants in the study will be randomly assigned to receive either KETOSTERIL or a placebo. The study will last for up to 12 months, during which participants will take the medication orally in the form of film-coated tablets. Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition.

During the study, the main focus will be on measuring the maximum loss of lean body mass, which is the weight of muscles and other non-fat tissues in the body, over a period of six months. Other aspects that will be observed include changes in walking distance, handgrip strength, and levels of certain substances in the blood, such as serum albumin and low-density lipoprotein (LDL). The study aims to provide valuable information on whether KETOSTERIL can help manage protein-energy wasting in people with nephrotic syndrome.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures of the trial. You will be asked to provide consent to participate.

You will undergo initial assessments to confirm eligibility, including tests to measure serum albumin levels and daily protein loss in urine.

2 receiving the medication

You will receive the study medication, KETOSTERIL, which is a film-coated tablet. This medication contains ketoanalogues of essential amino acids.

The medication is taken orally. The specific dosage and frequency will be provided by the study team, and it is important to follow these instructions carefully.

3 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include various tests and assessments.

You will be asked to report any side effects or changes in your health to the study team.

4 assessments and tests

During the trial, you will undergo several assessments to measure changes in your body, such as lean body mass, handgrip strength, and walking distance.

Blood tests will be conducted to monitor levels of serum albumin, low-density lipoprotein (LDL), triglycerides, and uric acid.

5 completion of the study

The study will last for approximately six months. At the end of the study, you will have a final assessment to evaluate the overall effects of the medication.

You will be informed about the results of the study and any further steps, if necessary.

Who Can Join the Study?

Must have nephrotic syndrome with blood protein levels (serum albumin) less than 3.0 g/dL and daily protein loss in urine (proteinuria) more than 3.5 g/day or more than 50 mg/kg.
Must be experiencing a new episode of nephrotic syndrome, which can be:
- New diagnosis of nephrotic syndrome with no previous kidney disease or treatment in the last 28 days.
- Persistent nephrotic syndrome despite treatment started more than 28 days ago.
- Relapse of nephrotic syndrome after at least partial improvement, shown by:
  - At least one daily protein loss in urine less than 2 g/day.
  - At least one urine test showing protein-to-creatinine ratio less than 2000 mg/g.
  - At least one urine test showing no or trace protein.
No previous treatment with immune system suppressing drugs, or if treated, must meet these conditions:
- For glucocorticoids (GCs), the average daily dose in the last 3 months was no more than 10 mg of prednisone, and no intravenous GCs were used in the 14 days before joining the study.
- Use of other immune system suppressing drugs (like calcineurin inhibitors, mycophenolate mofetil, cyclophosphamide, rituximab) before joining the study is allowed.
Must have a glomerular filtration rate (a measure of kidney function) of 30 mL/min/1.73m² or higher, based on a specific calculation method (CKD-EPI 2021).
Must be at least 18 years old.

Who Cannot Join the Study?

Patients who are not experiencing protein-energy wasting in nephrotic syndrome cannot participate. (Protein-energy wasting means a loss of muscle and fat tissue due to illness.)
Patients who do not have moderate to very severe nephrotic syndrome cannot participate. (Nephrotic syndrome is a kidney disorder that causes the body to excrete too much protein in the urine.)
Patients who are not within the specified age range cannot participate. (The age range is not specified here, but it is important to check if you fall within the eligible age group.)
Patients who are not part of the specified clinical trial group cannot participate. (The specific group is not detailed here, but it is important to verify if you belong to the eligible group.)
Patients who are not part of the vulnerable population selected for this study cannot participate. (A vulnerable population may include groups like children, pregnant women, or those with certain health conditions.)

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II	Grodzisk Mazowiecki	Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Radomski Szpital Specjalistyczny Im. Dr Tytusa Chałubinskiego	Radom	Poland
Uwmgdztzzyawqx Cstvidi Kdopsrjfr	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.12.2022

Trial locations

Investigated drugs:

Ketoanalogues of Essential Amino Acids are special supplements that are used in this clinical trial to help prevent muscle loss in patients with nephrotic syndrome, a kidney condition. These supplements are designed to provide the body with important building blocks that are similar to amino acids, which are the components of proteins. By using these ketoanalogues, the trial aims to see if they can help maintain muscle mass and improve the overall health of patients who are experiencing protein-energy wasting due to their condition.

Investigated diseases:

Nephrotic syndrome

Protein-energy wasting in nephrotic syndrome – Protein-energy wasting in nephrotic syndrome is a condition characterized by the loss of muscle mass and fat tissue due to inadequate protein and energy intake or increased protein loss. It occurs in individuals with nephrotic syndrome, a kidney disorder that causes the body to excrete too much protein in the urine. As the condition progresses, patients may experience a significant reduction in lean body mass, which can lead to decreased physical strength and endurance. The loss of muscle mass is often accompanied by changes in blood levels of proteins and lipids. This condition can also result in decreased serum albumin levels and altered lipid profiles, such as increased low-density lipoprotein and triglycerides. Monitoring changes in body composition and nutritional status is crucial in managing this condition.

Trial ID:

2024-517880-22-00

Protocol code:

ABM/FORMA/2021

NCT ID:

NCT05716880

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?