Table of contents

• Trials overview
• Stage 4 and 5 chronic kidney disease
• Nephrotic syndrome and protein-energy wasting
• Incremental haemodialysis
• What the trials measure
• Who can participate
• Trial phases and study design

Trials overview

Three authorised interventional trials are studying Hydroxi-Methionine Calcium in kidney-related settings, using the product names Ketosteril or ketoanalogues of essential amino acids in the trial records.^[1][2][3]

All three trials focus on nutrition, muscle protection, or dialysis-related care in people with kidney disease.^[1][2][3]

Stage 4 and 5 chronic kidney disease

The first trial studies patients with stage 4 and 5 chronic kidney disease who follow a moderately low protein diet of 0.6 to 0.8 g/kg/day.^[1]

This Phase 3 study aims to see whether supplementation can help with sarcopenia, which means loss of muscle mass, after 12 months.^[1]

The main outcome is the muscle mass index measured by DEXA, also called appendicular lean mass, which looks at lean muscle in the arms and legs.^[1]

Nephrotic syndrome and protein-energy wasting

The second trial is a multicentre randomized-controlled Phase 3 study in people with protein-energy wasting in nephrotic syndrome.^[2]

Its goal is to evaluate the efficacy, safety, and tolerability of the study treatment in the prevention of muscle loss in patients with moderate to very severe nephrotic syndrome.^[2]

The main outcome is change in lean body mass from baseline within 6 weeks after enrollment, and the study uses a non-inferiority design.^[2]

Incremental haemodialysis

The third trial is an exploratory randomized controlled Phase 2 study in incident haemodialysis patients starting incremental haemodialysis.^[3]

Incremental haemodialysis means dialysis given less than 3 times per week, except in palliative or end-of-life care situations.^[3]

This trial checks whether adding Ketosteril to the usual nutritional plan can extend the duration of the incremental haemodialysis period.^[3]

The primary endpoint is the number of months patients stay in this dialysis schedule.^[3]

What the trials measure

Across the studies, the main outcomes focus on muscle and nutrition, or on how dialysis is delivered over time.^[1][2][3]

• Appendicular lean mass: the amount of lean muscle in the arms and legs, measured with DEXA in the CKD trial.^[1]

• Change in lean body mass: a short-term measure used in the nephrotic syndrome trial to see if muscle loss can be prevented.^[2]

• Duration of incremental haemodialysis: the number of months a patient can stay on a reduced dialysis schedule in the dialysis trial.^[3]

Who can participate

The trials are designed for specific patient groups, not for the general public.^[1][2][3]

• Patients with stage 4 or 5 chronic kidney disease who are already on a moderately low protein diet.^[1]

• Patients with moderate to very severe nephrotic syndrome and protein-energy wasting.^[2]

• Incident haemodialysis patients who begin incremental haemodialysis.^[3]

Trial phases and study design

Two studies are in Phase 3, which usually means a larger test of benefit in patient groups, and one is in Phase 2, which often looks more closely at early effectiveness and safety signals.^[1][2][3]

All three are interventional trials, meaning the researchers give the study treatment and then measure the results.^[1][2][3]

One trial is multicentre and randomized-controlled, which means it takes place at more than one site and assigns participants by chance to compare treatment effects.^[2]

Another is described as exploratory, which means it is checking whether the approach is promising and worth further study.^[3]