In short
Clinical trials investigating Glycine are studying different hospital uses, mainly in transplant, surgery, and nutrition settings. These studies aim to check safety, organ protection, and recovery in adults and children, including living donor transplant patients, heart and liver transplant patients, and people on hemodialysis.
Key points
- Clinical trials investigating Glycine are being done in several hospital settings, especially transplantation, surgery, and nutrition support. The studies include both Phase 2 and Phase 3 trials, so they are looking at safety as well as whether the treatment helps patients recover better. Target groups include adults and children, such as living kidney donors, transplant recipients, patients on hemodialysis, and children having heart surgery. The main outcomes include kidney function, liver injury markers, graft function, infection rates, muscle protein synthesis, and adverse events. Several trials compare Glycine-related organ preservation or nutrition approaches with standard treatments. One trial is suspended, while the others are authorised.
Trial overview
The clinical trials investigating Glycine are not about one single disease. They are testing hospital treatments in several settings, including kidney, liver, and heart transplantation, surgery, and nutrition support for very sick patients.
Most of the studies are interventional, which means researchers give a treatment and compare it with another treatment or with standard care.
Who is being studied
The target populations include people with living donor renal transplantation, chronic hemodialysis patients, children with congenital heart malformation having cardiac surgery, patients after oesophagectomy, adults after major emergency abdominal surgery, and people undergoing kidney, liver, or kidney-pancreas transplantation.
Some studies are in adults, while others are in children, so the research covers both age groups.
Trial phases and study design
The listed studies are mainly in Phase 2 and Phase 3.
Phase 2 studies in this group focus on safety and early signs of benefit, such as in pediatric heart transplantation and congenital heart surgery.
Phase 3 studies are larger and usually compare treatments to see whether one option performs better or is not worse than the other in outcomes that matter to patients, such as graft function, infection risk, or muscle loss.
Main endpoints and what they mean
The primary outcome is the main result a trial wants to measure.
In these studies, the main outcomes include kidney function after transplant, muscle protein synthesis during nutrition treatment, safety through reporting of adverse events, muscle size after surgery, infection rates during hospital stay, and liver injury measured by ALT or GPT over time.
Some studies use special measures such as plasma clearance of iohexol for kidney function, CK-MB levels for heart muscle protection, CT scan for muscle size, and AUC, which means the result is tracked over several days rather than at one time point.
Study-by-study summary
Living donor renal transplantation study: This Phase 3 trial in 60 people is studying how kidney function changes in donors and recipients after transplant, and it measures renal reserve before surgery using an amino acid infusion.
LOTUS: This Phase 3 study in 20 chronic hemodialysis patients is looking at muscle protein synthesis during one week of IDPN treatment, which is intravenous nutrition given through the vein.
Custodiol-N versus Custodiol in children with congenital heart malformation: This Phase 2 study in 100 children was planned to compare safety and myocardial protection, but its status is suspended.
Route of nutrition and muscle wasting after oesophagectomy: This Phase 3 trial in 38 patients is studying whether the route of nutrition affects loss of muscle after oesophagectomy, with muscle size measured by CT scan.
Early versus postponed supplementary parenteral nutrition after major emergency abdominal surgery: This Phase 3 study in 342 patients is comparing early and delayed nutrition support to see whether infections during the hospital stay are reduced.
Custodiol-N in kidney, liver, and kidney-pancreas transplantation: This Phase 3 study in 362 patients is testing whether organ preservation with Custodiol-N is not worse than Custodiol, with endpoints that include delayed graft function for kidney and ALT-based liver injury measures for liver transplant.
Custodiol-N versus Custodiol in children having heart transplantation: This Phase 2 study in 15 children is focused on safety, with adverse events tracked for up to 3 months.
Custodiol-N versus Custodiol in liver transplantation: This Phase 3 study in 200 patients is measuring liver injury after transplant using GPT (ALT) over 7 days, with daily tests in the first week.
What these trials show so far
From the available trial records, the main goal is to learn whether these study treatments can better protect organs, support nutrition, or reduce complications during and after major medical procedures.
The evidence here is still coming from ongoing or planned research, so these records describe study aims and endpoints rather than final results.