In short
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.
Key points
- Clinical trials of Alpha-Ketophenylalanine Calcium are focused on kidney-related conditions. The studies include people with advanced chronic kidney disease, nephrotic syndrome, and incident haemodialysis. Researchers are mainly looking at muscle protection, lean body mass, protein-energy wasting, and the length of the incremental haemodialysis period. The trials are in Phase 2 and Phase 3, so they are testing both effectiveness and safety-related outcomes. All listed studies are authorised and are interventional trials. One study also uses DEXA to measure appendicular lean mass, which is muscle in the arms and legs.
Clinical trials overview
The available trials of Alpha-Ketophenylalanine Calcium are studying kidney-related conditions and nutrition problems. These studies are asking whether the treatment may help protect muscle, reduce protein-energy wasting, and support patients during dialysis care. 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.
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. Another trial includes patients with moderate to very severe nephrotic syndrome and focuses on prevention of muscle loss and protein-energy wasting. The third trial includes incident haemodialysis patients, meaning people who have recently started dialysis, and it studies the incremental haemodialysis period.
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.
What the trials measure
The first study measures muscle mass index at 12 months using DEXA, a scan that can measure body composition. It focuses on appendicular lean mass, which means lean muscle in the arms and legs. The goal is to see whether treatment helps protect muscle in advanced kidney disease.
The second study measures change in lean body mass within 6 weeks after enrollment. 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. The study also evaluates efficacy, safety, and tolerability, meaning whether the treatment works, whether it is safe, and how well patients can take it.
The third study measures the duration of the incremental haemodialysis period in months. In this study, incremental haemodialysis means fewer than 3 dialysis sessions per week, except in palliative or end-of-life care. Researchers want to know whether adding Alpha-Ketophenylalanine Calcium to the usual nutrition plan can help prolong this period.
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. The third study is in Phase 2, which is often used to explore whether a treatment shows benefit in a smaller group of patients.
All three trials are interventional and use oral treatment forms of Ketosteril listed in the source data. 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.
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. 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.
NCT05716880 is a Phase 3 multicentre randomized-controlled trial in nephrotic syndrome. It studies prevention of protein-energy wasting and muscle loss, and it measures lean body mass over 6 weeks.
2025-524093-41-00 is a Phase 2 exploratory randomized controlled trial in incident haemodialysis patients. It looks at whether adding Ketosteril to the usual nutrition plan can extend the incremental haemodialysis period.
Patient glossary
Authorised means the study has been approved to run, according to the source data. Enrollment means the planned number of patients the study hopes to include. Randomized-controlled trial means patients are assigned by chance to study groups, which helps make the results more reliable.
Primary outcome is the main result the trial is designed to measure. In these studies, the main results are muscle mass, lean body mass, and the length of the incremental haemodialysis period. Tolerability means how well patients can take the study treatment in daily life.