Hydroxi-Methionine Calcium clinical trials in kidney disease and dialysis

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.123

All three trials focus on nutrition, muscle protection, or dialysis-related care in people with kidney disease.123

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.123

• 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.123

• 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.123

All three are interventional trials, meaning the researchers give the study treatment and then measure the results.123

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