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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with chronic kidney disease (CKD), specifically those in stages 4 and 5. The study aims to explore the effects of a treatment called Ketoanalogue supplementation on muscle health. Ketoanalogue supplementation involves taking a medication known as Ketosteril Ketoacid film-coated tablets, which contains a combination of substances like L-lysine acetate, L-tryptophan, and L-histidine, among others. These tablets are designed to help protect muscle mass in patients who are following a moderately low protein diet.

The purpose of the study is to determine how effective Ketoanalogue supplementation is in preventing muscle loss, a condition known as sarcopenia, over a period of 12 months. Participants will be asked to take the tablets orally and will have their muscle mass and other health indicators monitored at various intervals throughout the study. This includes checking their weight, body mass index (BMI), and levels of certain proteins and minerals in the blood. The study will also assess muscle strength and performance through tests like grip strength and walking speed.

By participating in this study, researchers hope to gather valuable information on how Ketoanalogue supplementation can benefit patients with advanced stages of chronic kidney disease. The ultimate goal is to improve the quality of life for these patients by maintaining their muscle health while they manage their kidney condition with a low protein diet.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Introduction to the trial
Upon joining the study, the patient will receive an overview of the trial's purpose, which is to assess the effect of ketoanalogue supplementation on muscle protection in individuals with stage 4 or 5 chronic kidney disease (CKD) following a moderately low protein diet.
Step 2
Medication administration
The patient will be prescribed Ketosteril Ketoacid film-coated tablets, which are taken orally. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.
Step 3
Dietary monitoring
The patient's protein intake will be monitored to ensure it remains between 0.6 and 0.8 grams per kilogram per day, as estimated through dietary surveys.
Step 4
Regular assessments
The patient will undergo regular assessments at 3, 6, 9, and 12 months. These assessments will include measurements of weight, body mass index (BMI), and various blood markers such as albumin, prealbumin, C-reactive protein (CRP), serum lipids, glycemia, serum calcium, phosphate, parathormone, and vitamin D levels.
Step 5
Muscle and bone evaluations
At 12 months, the patient will have their muscle mass index measured using a DEXA scan, which evaluates appendicular lean mass. Additional tests will include grip strength, muscle performance through a walking speed test, and bone mineral density.
Step 6
Monitoring kidney function
The patient's kidney function will be monitored throughout the trial, with specific attention to estimated glomerular filtration rate (GFR) and proteinuria at 12 months.
Step 7
End of trial
The trial is expected to conclude by December 1, 2028. At this point, the patient will have a final evaluation to assess the overall impact of the treatment on muscle protection and kidney function.

Who can join the trial?

5 criteria

Men or women older than 18 years
Have Stage 4 or 5 Chronic Kidney Disease (CKD). This means the kidneys are not working well, with a specific measure called eGFR (estimated glomerular filtration rate) being less than 30 mL/min/1.73 m². This is calculated using a formula called the CKD-EPI 2009 creatinine equation.
Consume a specific amount of protein in their diet, between 0.6 and 0.8 grams per kilogram of body weight per day. This is estimated using a dietary survey.
Have social security coverage
Provide written informed consent, which means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

10 criteria

Patients with any other serious health condition that might interfere with the study.
Patients who are unable to follow the study procedures or instructions.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are planning to have one during the study period.
Patients with a known allergy to the study medication or its ingredients.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients who have a mental health condition that might affect their ability to participate.
Patients who have been diagnosed with cancer in the past five years.
Patients with uncontrolled high blood pressure.

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University Hospital Of Clermont-Ferrand
Clermont Ferrand, France

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Investigated drugs

Ketoanalogue is a supplement used in this trial to help protect muscles in patients with advanced chronic kidney disease (CKD). It is designed to provide essential nutrients that the body needs, especially when protein intake is limited. This supplement aims to prevent muscle loss, known as sarcopenia, by providing building blocks that the body can use to maintain muscle mass even with a low-protein diet.

What is already known about the treatment

Ketoanalogue Supplementation – This medication is administered orally in the form of tablets or capsules. It is currently being studied in clinical trials for its potential benefits in patients with chronic kidney disease (CKD), particularly those in stages 4 and 5. The main therapeutic indication is to protect muscle mass in these patients who are on a moderately low protein diet. At the molecular level, ketoanalogues work by providing essential amino acids without adding nitrogen load, which helps in reducing the burden on the kidneys. It is classified under nutritional supplements, specifically designed to support patients with kidney disease.

Investigated diseases

Chronic Kidney Disease (CKD) – This condition involves the gradual loss of kidney function over time. In the later stages, waste products and excess fluids can build up in the body, leading to symptoms such as swelling, fatigue, and difficulty concentrating. As the disease progresses, the kidneys' ability to filter blood diminishes, which can affect other bodily functions. Stage 4 or 5 CKD indicates severe kidney damage, where the kidneys are functioning at less than 30% of their normal capacity. This stage often requires careful management of diet and lifestyle to slow further progression. Eventually, advanced CKD may necessitate dialysis or kidney transplantation to maintain health.