In short
Clinical trials investigating Aspartic Acid are studying organ preservation and related outcomes in transplant surgery, as well as muscle protein turnover in hemodialysis. These studies look at safety, graft function, and other measures in children and adults. The target groups include patients undergoing kidney, liver, pancreas, heart, and cardiac surgery, plus chronic hemodialysis patients.
Key points
- Clinical trials investigating Aspartic Acid are focused on transplant surgery and hemodialysis-related care. Most studies compare organ preservation solutions, especially in kidney, liver, pancreas, and heart settings. The trial phases include Phase 2 and Phase 3, with both small pediatric studies and larger adult transplant studies. Main outcomes include safety, graft function, delayed graft function, liver blood tests, heart muscle injury markers, and muscle protein synthesis. One study is suspended, while the others are authorised. The target populations include children and adults undergoing transplantation, plus chronic hemodialysis patients.
Trial overview
The clinical trials linked to Aspartic Acid in the source data are all interventional studies, which means the researchers give a treatment and then measure the results.
These studies are being done in transplantation, pediatric heart surgery, and hemodialysis, with both Phase 2 and Phase 3 trials reported.
Transplant studies and organ preservation
Three trials are focused on organ preservation, which means keeping an organ in good condition before it is transplanted.
One Phase 3 study includes patients who will undergo kidney, liver, or kidney-pancreatic transplantation and compares Custodiol-N with Custodiol to see whether graft preservation is non-inferior, meaning not worse than the comparison treatment.
Another Phase 3 liver transplantation study compares Custodiol-N with Custodiol and measures liver test results after surgery over 7 days.
Both transplant studies are authorised and use the same general research idea: compare organ preservation solutions and check how well the transplanted organ works after surgery.
Pediatric heart studies
Two studies involve children having heart-related surgery.
The authorised Phase 2 trial studies heart transplantation in children and compares Custodiol-N with Custodiol, with safety checked through continuous adverse event reporting for up to 3 months.
The suspended Phase 2 trial studies children with congenital heart malformation, which means a heart problem present at birth, and compares two cardioplegia methods during cardiac surgery.
In that study, the researchers also look at myocardial protection, meaning how well the heart muscle is protected during surgery, by measuring CK-MB levels after the operation.
Hemodialysis and muscle protein turnover
One Phase 3 trial, called LOTUS, studies chronic hemodialysis patients and looks at muscle protein turnover, which is the balance between making and breaking down muscle protein.
The study aims to see the effect of IDPN on muscle protein synthesis and to describe hemodynamic effects, meaning effects on blood flow and circulation.
This is a small authorised study with 20 participants and a one-week treatment period compared with control.
Main outcomes and endpoints
The main outcomes differ by study, but they all focus on how well the treatment works and how safe it is.
- Kidney transplant outcome: delayed graft function, which means the new kidney does not start working right away.
- Liver transplant outcomes: GPT (ALT) measured over 7 days and analyzed as an AUC, which shows the overall pattern of the liver blood test over time.
- Pediatric heart transplant safety: continuous adverse event reporting for up to 3 months.
- Cardiac surgery safety and protection: adverse events up to 30 days after surgery and CK-MB levels up to day 7 or discharge.
- Hemodialysis outcome: difference in myofibrillar fractional synthetic rate during one week of treatment versus control.
Study status and enrollment
Most of the trials are authorised, while one pediatric cardiac surgery study is suspended.
Enrollment ranges from 15 participants in the smallest pediatric heart transplantation study to 362 participants in the largest transplant study.
Overall, the trials show a research program centered on transplant support, surgical protection, and post-treatment recovery measures in children and adults.