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Alpha-Ketophenylalanine Calcium

Clinical trials of Alpha-Ketophenylalanine Calcium are studying whether it can help protect muscle and support nutrition in people with kidney-related conditions. The trials look at safety, tolerability, and effectiveness in patients with chronic kidney disease, nephrotic syndrome, and incident haemodialysis.

Table of contents

Clinical trials overview

The available trials of Alpha-Ketophenylalanine Calcium are studying kidney-related conditions and nutrition problems.[1][2][3] These studies are asking whether the treatment may help protect muscle, reduce protein-energy wasting, and support patients during dialysis care.[1][2][3] All three listed studies are marked as authorised and are interventional trials, which means the researchers give the study treatment and then track the results.[1][2][3]

Who the trials include

One trial includes people with stage 4 or 5 chronic kidney disease who eat a moderately low protein diet of 0.6 to 0.8 g/kg/day.[1] Another trial includes patients with moderate to very severe nephrotic syndrome and focuses on prevention of muscle loss and protein-energy wasting.[2] The third trial includes incident haemodialysis patients, meaning people who have recently started dialysis, and it studies the incremental haemodialysis period.[3]

These trials are not testing the same group of patients, but they share a common goal: to see whether Alpha-Ketophenylalanine Calcium can help people with kidney disease keep more muscle or maintain a better nutrition status.[1][2][3]

What the trials measure

The first study measures muscle mass index at 12 months using DEXA, a scan that can measure body composition.[1] It focuses on appendicular lean mass, which means lean muscle in the arms and legs.[1] The goal is to see whether treatment helps protect muscle in advanced kidney disease.[1]

The second study measures change in lean body mass within 6 weeks after enrollment.[2] It is designed as a non-inferiority study, which checks whether the treatment is not worse than the comparison by more than a set amount.[2] The study also evaluates efficacy, safety, and tolerability, meaning whether the treatment works, whether it is safe, and how well patients can take it.[2]

The third study measures the duration of the incremental haemodialysis period in months.[3] In this study, incremental haemodialysis means fewer than 3 dialysis sessions per week, except in palliative or end-of-life care.[3] Researchers want to know whether adding Alpha-Ketophenylalanine Calcium to the usual nutrition plan can help prolong this period.[3]

Trial phases and design

Two of the studies are in Phase 3, which usually means a larger study that looks more closely at how well the treatment works and collects more safety information.[1][2] The third study is in Phase 2, which is often used to explore whether a treatment shows benefit in a smaller group of patients.[3]

All three trials are interventional and use oral treatment forms of Ketosteril listed in the source data.[1][2][3] The source data also shows planned enrollment of 100 patients in the CKD study, 150 patients in the nephrotic syndrome study, and 70 patients in the haemodialysis study.[1][2][3]

Key trials

2024-516764-29-00 is a Phase 3 study in stage 4 and 5 chronic kidney disease with a moderately low protein diet.[1] It measures appendicular lean mass by DEXA after 12 months and aims to see whether supplementation can help with sarcopenia, which means loss of muscle mass and strength.[1]

NCT05716880 is a Phase 3 multicentre randomized-controlled trial in nephrotic syndrome.[2] It studies prevention of protein-energy wasting and muscle loss, and it measures lean body mass over 6 weeks.[2]

2025-524093-41-00 is a Phase 2 exploratory randomized controlled trial in incident haemodialysis patients.[3] It looks at whether adding Ketosteril to the usual nutrition plan can extend the incremental haemodialysis period.[3]

Patient glossary

Authorised means the study has been approved to run, according to the source data.[1][2][3] Enrollment means the planned number of patients the study hopes to include.[1][2][3] Randomized-controlled trial means patients are assigned by chance to study groups, which helps make the results more reliable.[2][3]

Primary outcome is the main result the trial is designed to measure.[1][2][3] In these studies, the main results are muscle mass, lean body mass, and the length of the incremental haemodialysis period.[1][2][3] Tolerability means how well patients can take the study treatment in daily life.[2]

Trial ID Phase Condition studied Status Enrollment
2024-516764-29-00 Phase 3 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

  • What are the clinical trials of Alpha-Ketophenylalanine Calcium studying? The trials are studying whether Alpha-Ketophenylalanine Calcium can help protect muscle and reduce protein-energy wasting, which means loss of body protein and energy stores. They also look at whether it can support patients during incremental haemodialysis.
  • Who can take part in these trials? The target groups include people with stage 4 or 5 chronic kidney disease, patients with moderate to very severe nephrotic syndrome, and incident haemodialysis patients. One study also includes people with a moderately low protein diet.
  • What phases are the trials in? The trials are in Phase 2 and Phase 3. These phases are used to study how well the treatment works and to gather more information on safety and tolerability.
  • What outcomes are being measured? The studies measure muscle mass, lean body mass, and the duration of the incremental haemodialysis period. One trial also looks at sarcopenia, which means loss of muscle mass and strength.
  • Are the trials already running? Yes. All three trials listed are marked as authorised. They are interventional studies, which means the researchers give the study treatment and then measure the results.

Ongoing Clinical Trials on Alpha-Ketophenylalanine Calcium

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

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Ketosteril Added to Usual Nutrition for Patients Starting Incremental Haemodialysis with Incremental Haemodialysis

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Chronic kidney disease (CKD): A long-term condition where the kidneys do not work well. In the trials, patients with stage 4 or 5 CKD are included, which means advanced kidney disease.
  • Stage 4 and 5 CKD: Later stages of chronic kidney disease. These patients have more severe kidney problems and may be close to needing dialysis.
  • Nephrotic syndrome: A kidney condition that can cause protein loss in the urine and swelling. The trial studies patients with moderate to very severe nephrotic syndrome.
  • Protein-energy wasting: A loss of body protein and energy stores. It can lead to weakness and muscle loss, especially in people with kidney disease.
  • Sarcopenia: Loss of muscle mass and muscle strength. One trial measures this outcome after 12 months.
  • Lean body mass: The amount of body weight that is not fat. It includes muscle and is used to see whether the treatment helps preserve body tissue.
  • Appendicular lean mass: Lean muscle mass in the arms and legs. One trial measures this with DEXA scanning.
  • DEXA: A scan used to measure body composition, including muscle and bone. In the trial, it is used to measure appendicular lean mass.
  • Incremental haemodialysis: A dialysis schedule with fewer than 3 sessions per week. One trial studies whether adding Alpha-Ketophenylalanine Calcium can help keep this period longer.
  • Non-inferiority: A study design that checks whether one treatment is not worse than another by more than a set amount.
  • Interventional study: A trial where researchers give a treatment or intervention and then measure the results.

References

  1. https://clinicaltrials.gov/study/2024-516764-29-00
  2. https://clinicaltrials.eu/trial/study-on-the-effectiveness-of-ketoanalogues-in-preventing-muscle-loss-in-patients-with-nephrotic-syndrome/
  3. https://clinicaltrials.gov/study/2025-524093-41-00