Table of Contents

• Trial overview
• Transplant studies
• Pediatric heart studies
• Nutrition and muscle studies
• Endpoints and measures
• Status and participation

Trial overview

The trial data for Alanine includes studies in organ preservation, heart transplantation, cardiac surgery, hemodialysis, and nutrition support after major surgery.^{[1][2][3][4][5][6][7]}

Most of the studies are interventional, which means the researchers assign a treatment and compare outcomes between groups.^{[1][2][3][4][5][6][7]}

The trials are mainly in Phase 2 and Phase 3, showing that the studies are focused on safety, comparison, and clinical results in patient groups already defined by their condition.^{[1][2][3][4][5][6][7]}

Transplant studies

Two Phase 3 trials study organ preservation solutions in people having kidney, liver, or kidney-pancreas transplantation, and in people having liver transplantation alone.^[1][3]

These studies compare Custodiol-N with Custodiol, and their goal is to see whether graft preservation with Custodiol-N is not worse than the comparison treatment, which is called non-inferiority.^[1]

In the larger transplant study, the main kidney endpoint is delayed graft function, while the liver endpoint is the area under the curve of GPT (ALT) during the first 7 days after implantation.^[1]

In the liver-only trial, the main endpoint is also the area under the curve of GPT (ALT) during 7 days after transplantation, with daily measurements in the first week.^[3]

These transplant studies are important because they look at how well the transplanted organ works after surgery and how much early injury may have happened.^[1][3]

Pediatric heart studies

Two studies focus on children having heart transplantation or cardiac surgery for congenital heart malformation, which means a heart problem present from birth.^[2][5]

The heart transplantation study is Phase 2 and compares Custodiol-N with Custodiol in a very small group of 15 children.^[2]

Its main endpoint is safety assessment, based on continuous reporting of adverse events for up to 3 months.^[2]

The congenital heart surgery study is also Phase 2, but it was suspended, and it planned to enroll 100 children.^[5]

Its main outcomes include safety over 30 days after surgery and myocardial protection, measured with CK-MB levels up to day 7 after surgery.^[5]

Nutrition and muscle studies

Three trials look at nutrition and metabolism after major illness or surgery.^[4][6][7]

The LOTUS study is Phase 3 and includes people on chronic hemodialysis, a treatment that cleans the blood when the kidneys do not work well.^[4]

This study looks at the difference in myofibrillar fractional synthetic rate, which is a measure of muscle protein building, during one week of treatment with IDPN versus control.^[4]

Another Phase 3 study follows patients after oesophagectomy, which is surgery to remove the esophagus, and measures muscle size by CT scan from before surgery to 10 days after surgery.^[6]

A third Phase 3 study looks at early versus postponed supplementary parenteral nutrition after major emergency abdominal surgery, with the main goal of reducing infectious complications during the hospital stay.^[7]

These studies show that the research is not only about surgery itself, but also about recovery, muscle loss, and nutrition support after major stress on the body.^[4][6][7]

Endpoints and measures

The main endpoints in these trials are practical clinical measures, such as whether the transplanted organ works, whether there are adverse events, and whether markers of injury improve.^[1][2][3][5]

Some studies use laboratory markers like GPT (ALT) and CK-MB, while others use imaging, such as CT scans, or clinical outcomes like infections and graft function.^{[1][3][5][6][7]}

One trial also uses the term area under the curve, which means the total change in a lab value over time, not just one single result.^[1][3]

Across the studies, the main focus is to compare treatment approaches in clearly defined patient groups and to measure recovery, safety, and early organ injury.^{[1][2][3][4][5][6][7]}

Status and participation

Most of the trials are listed as Authorised, which means they are approved to run, while one pediatric cardiac surgery study is Suspended.^{[1][2][3][4][5][6][7]}

Enrollment numbers are small in some studies, such as 15 children in the heart transplantation trial and 20 people in the hemodialysis study, while other studies are much larger, such as 362 participants in the transplant preservation trial and 342 in the emergency abdominal surgery nutrition trial.^[1][2][4][7]

This means the trials are designed for specific patient groups, and each one asks a different clinical question about treatment choice, safety, or recovery.^{[1][2][3][4][5][6][7]}