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Hydroxi-Methionine Calcium

Questo articolo riassume gli studi clinici su Hydroxi-Methionine Calcium, valutato in pazienti con malattia renale cronica, sindrome nefrosica e emodialisi incrementale. I trial analizzano soprattutto efficacia, sicurezza e tollerabilità, con l’obiettivo di proteggere la massa muscolare e migliorare alcuni esiti nutrizionali.

Table of contents

Overview of the clinical trials

The available clinical trials on Hydroxi-Methionine Calcium focus on people with kidney-related conditions and nutritional risk.[1][2][3] These studies are testing whether the treatment can help protect muscle mass, reduce muscle loss, and support nutritional care in specific patient groups.[1][2][3]

Main studies and target populations

One Phase 3 study, 2024-516764-29-00, is in patients with chronic kidney disease stage 4 and 5 who follow a moderately low-protein diet.[1] The study aims to see whether ketoanalogue supplementation can help protect against sarcopenia, which means loss of muscle mass and strength.[1]

A second Phase 3 study, NCT05716880, is a multicentre randomized-controlled trial in people with protein-energy wasting in nephrotic syndrome.[2] This trial looks at whether the treatment can help prevent muscle loss in patients with moderate to very severe nephrotic syndrome and also checks safety and tolerability.[2]

The third study, 2025-524093-41-00, is a Phase 2 exploratory randomized controlled trial in incident haemodialysis patients starting incremental haemodialysis.[3] It tests whether adding Hydroxi-Methionine Calcium to the usual nutritional plan can affect the length of the incremental haemodialysis period.[3]

What the trials measure

The main outcome in 2024-516764-29-00 is the muscle mass index measured by DEXA at 12 months.[1] DEXA is a scan used to measure body composition, and in this study the focus is on appendicular lean mass, which means lean tissue in the arms and legs.[1]

In NCT05716880, the main outcome is the change in lean body mass from baseline within 6 weeks after enrollment, using a non-inferiority design.[2] A non-inferiority study checks whether the new approach is not worse than the comparison by more than a set amount.[2]

In 2025-524093-41-00, the main outcome is the duration in months of the incremental haemodialysis period.[3] The study defines this as dialysis fewer than 3 times per week, excluding cases where the schedule is reduced because of palliative or end-of-life care.[3]

Trial phases and study design

Two of the studies are in Phase 3, which means they are testing the treatment in larger groups and looking more closely at benefit and safety.[1][2] The third study is in Phase 2, which is earlier and usually explores whether there are early signs that the treatment may help.[3]

All three studies are interventional, which means the researchers give the study treatment and then measure the results.[1][2][3] All are listed as authorised and have planned enrollment of 100, 150, and 70 participants, respectively.[1][2][3]

Who may take part

The trials are aimed at adults with advanced kidney disease or related nutritional problems.[1][2][3] More specifically, the data mention patients with stage 4 or 5 chronic kidney disease, patients with nephrotic syndrome and protein-energy wasting, and patients who are starting incremental haemodialysis.[1][2][3]

One study also specifies a dietary protein intake between 0.6 and 0.8 g/kg/day.[1] This means the trial is looking at people who already follow a controlled, lower-protein diet as part of their kidney care.[1]

Patient-friendly explanation of key terms

Sarcopenia means loss of muscle mass, and it can make a person weaker or less able to move well.[1] Protein-energy wasting means the body is losing important nutrition stores, which can lead to weight and muscle loss.[2]

Lean body mass is the amount of the body that is not fat, including muscles and other tissues.[2] Appendicular lean mass is the lean tissue in the arms and legs, which helps researchers estimate muscle status.[1]

Incremental haemodialysis is a dialysis schedule that starts with fewer than 3 sessions per week.[3] In the trial data, the researchers are studying whether adding Hydroxi-Methionine Calcium can help patients stay in this phase for a longer time.[3]

Trial ID Phase Condition studied Status Enrollment
2024-516764-29-00 Phase 3 Kidney disease; stage 4 and 5 chronic kidney disease with moderately low protein diet Authorised 100
NCT05716880 Phase 3 Protein-energy wasting in nephrotic syndrome Authorised 150
2025-524093-41-00 Phase 2 Incremental haemodialysis Authorised 70

FAQ

  • Who is being studied in the trials of Hydroxi-Methionine Calcium? The trials focus on adults with stage 4 or 5 chronic kidney disease, people with nephrotic syndrome, and patients starting incremental haemodialysis. These are groups with kidney-related conditions and nutritional risk.
  • What are the trials trying to find out? They are mainly looking at whether Hydroxi-Methionine Calcium can help protect muscle mass and reduce muscle loss. Some studies also assess safety, tolerability, and how long certain dialysis periods can be maintained.
  • What phases are the trials in? The available studies are in Phase 2 and Phase 3. This means some trials are exploring early clinical benefit, while others are testing the treatment in larger patient groups.
  • What conditions are being studied? The main conditions are chronic kidney disease, protein-energy wasting in nephrotic syndrome, and incremental haemodialysis. All of these involve kidney disease and problems with nutrition or muscle loss.
  • What outcomes are measured in these trials? The studies measure lean body mass, muscle mass index, and the duration of the incremental haemodialysis period. These endpoints help researchers see whether the treatment supports muscle preservation and treatment planning.

Sperimentazioni cliniche in corso su Hydroxi-Methionine Calcium

  • Studio sull’uso di Ketoanalogo per proteggere i muscoli nei pazienti con malattia renale cronica stadio 4 e 5 con dieta a basso contenuto proteico.

    In arruolamento

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Francia

  • Studio sull’efficacia dei chetoanaloghi di amminoacidi essenziali nella prevenzione della perdita muscolare nei pazienti con sindrome nefrosica moderata o grave

    In arruolamento

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Polonia

  • Dialisi incrementale e malattia renale cronica nei pazienti che iniziano l’emodialisi: aggiunta di aminoacidi e chetoanaloghi alla dieta con Ketosteril

    Arruolamento non iniziato

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Francia

Glossario

  • Phase 2: A clinical trial stage that looks at early signs of benefit and continues to check safety in a smaller group of patients.
  • Phase 3: A later trial stage that tests a treatment in a larger group to better understand how well it works and how safe it is.
  • Interventional study: A study where researchers give a treatment or intervention and then measure what happens.
  • Chronic kidney disease: A long-term condition in which the kidneys do not work as well as they should.
  • Stage 4 and 5 CKD: Advanced stages of chronic kidney disease, when kidney function is severely reduced.
  • Nephrotic syndrome: A kidney condition that can cause heavy loss of protein in the urine and swelling.
  • Protein-energy wasting: A state of poor nutrition in which the body loses protein and energy stores, often leading to weight and muscle loss.
  • Lean body mass: The weight of the body minus fat. It includes muscles and other non-fat tissues.
  • DEXA: A scan used to measure body composition, including bone and muscle-related measures.
  • Appendicular lean mass: The amount of lean tissue in the arms and legs. It is often used to estimate muscle mass.
  • Incremental haemodialysis: A dialysis approach that starts with fewer sessions per week than standard dialysis.
  • Non-inferiority: A study goal that checks whether one treatment is not worse than another by more than a set amount.

Riferimenti

  1. https://clinicaltrials.gov/study/2024-516764-29-00
  2. https://studi-clinici.it/studio/studio-sullefficacia-dei-chetoanaloghi-di-amminoacidi-essenziali-nella-prevenzione-della-perdita-muscolare-nei-pazienti-con-sindrome-nefrosica-moderata-o-grave/
  3. https://clinicaltrials.gov/study/2025-524093-41-00