In short
Clinical trials investigating Arginine are studying different hospital settings, including transplantation and nutrition support. These studies look at safety, effectiveness, and recovery outcomes in adults and children. The target groups include people having liver, kidney, pancreas, heart, or emergency abdominal surgery, as well as patients on hemodialysis.
Key points
- Clinical trials investigating Arginine are focused on hospital care settings such as transplantation, heart surgery in children, hemodialysis, and nutrition after major surgery. Most of the studies are Phase 2 or Phase 3 trials, so they are checking both safety and how well the treatment works. The populations include children and adults, with several trials in transplant patients and surgical patients. Key endpoints include adverse events, graft function, liver enzyme changes, infection rates, muscle size, and muscle protein synthesis. One study is suspended, while the others are authorised.
Overview of the Arginine trial landscape
The trial data provided here includes studies that investigate Arginine in different hospital and surgical settings, especially organ preservation, transplantation, and nutrition support. The studies are mostly Phase 2 and Phase 3 trials, which means they are looking at safety and how well the study treatments work in real patients.
Several trials are authorised, while one trial is suspended. The populations include adults and children, with conditions such as liver transplantation, kidney transplantation, heart transplantation in children, congenital heart malformation in children, hemodialysis, oesophagectomy, and major emergency abdominal surgery.
Transplantation and organ preservation studies
One Phase 3 study in 200 liver transplant patients compares Custodiol-N with Custodiol for organ preservation during liver transplantation. The main endpoint is the area under the curve (AUC) of GPT, also called ALT, during the first 7 days after transplantation. This endpoint tracks liver injury over time rather than at only one blood test.
A second Phase 3 study looks at organ preservation in 362 patients having kidney, liver, or kidney-pancreatic transplantation. It compares Custodiol-N with Custodiol and aims to show non-inferiority, which means the new treatment should work at least not worse than the control treatment by a pre-set margin. The key outcomes are delayed graft function for kidney transplants and AUC of GPT (ALT) for liver transplants.
Children's heart studies
One Phase 2 trial studies organ perfusion in 15 children undergoing heart transplantation. It compares Custodiol-N with Custodiol and focuses on safety, with continuous reporting of adverse events for up to 3 months.
Another Phase 2 study includes 100 children with congenital heart malformation who need cardiac surgery. It compares two methods of cardioplegia, which means a controlled way to protect the heart during surgery. The study measures safety through adverse events up to 30 days after surgery and myocardial protection using CK-MB levels up to day 7 or discharge.
Nutrition and muscle studies
One Phase 3 trial called LOTUS includes 20 chronic hemodialysis patients and studies the effect of IDPN, which stands for intradialytic parenteral nutrition, meaning nutrition given through a vein during dialysis. The main endpoint is the difference in myofibrillar fractional synthetic rate during one week of treatment compared with control. This is a measure of how fast muscle protein is being made.
Another Phase 3 study in 38 patients after oesophagectomy looks at how the route of nutrition affects muscle wasting. It measures the change in muscle size on CT scan from before surgery to 10 days after the operation.
A further Phase 3 study in 342 patients after major emergency abdominal surgery compares early versus postponed supplementary parenteral nutrition. Its main outcome is the rate of infectious complications during the hospital stay.
Main endpoints and what they mean
The trials use different endpoints, which are the main results researchers want to measure. In the transplant studies, the focus is on liver enzyme changes and graft function, because these help show how well the transplanted organ is working.
In the pediatric heart studies, the endpoints focus on safety and heart muscle protection, using adverse event reports and CK-MB blood levels. In the nutrition studies, the endpoints look at muscle protein synthesis, muscle size, and infections after surgery.
Who the trials are for
The studies are not for one single disease. Instead, they include specific groups such as people having liver, kidney, pancreas, or heart transplantation, children with congenital heart malformation, patients on hemodialysis, and people recovering from major surgery. Some studies are designed for children, while others are for adults only.
Trial phases and status
Most of the trials listed are authorised, meaning they have been approved to proceed. One study is suspended, which means it is temporarily stopped.
The set of studies includes both Phase 2 and Phase 3 trials, showing that the research is moving from early safety checks to larger comparisons of effectiveness.