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Glycine

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.

Table of Contents

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.[1][2]

Most of the studies are interventional, which means researchers give a treatment and compare it with another treatment or with standard care.[1][2]

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.[1][2][3][4][5][6][7][8]

Some studies are in adults, while others are in children, so the research covers both age groups.[3][7]

Trial phases and study design

The listed studies are mainly in Phase 2 and Phase 3.[1][2][3][4][5][6][7][8]

Phase 2 studies in this group focus on safety and early signs of benefit, such as in pediatric heart transplantation and congenital heart surgery.[3][7]

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.[1][2][4][5][6][8]

Main endpoints and what they mean

The primary outcome is the main result a trial wants to measure.[1][2]

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.[1][2][3][4][5][6][7][8]

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.[1][3][4][6][7][8]

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.[1]

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.[2]

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.[3]

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.[4]

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.[5]

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.[6]

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.[7]

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.[8]

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.[1][2][4][5][6][8]

The evidence here is still coming from ongoing or planned research, so these records describe study aims and endpoints rather than final results.[1][2][3][4][5][6][7][8]

Trial IDPhaseCondition studiedStatusEnrollment
2024-519757-11-00Phase 3Living donor renal transplantationAuthorised60
2025-522111-42-02Phase 3Muscle protein turnover, hemodialysisAuthorised20
2024-511517-38-00Phase 2Congenital heart malformation in childrenSuspended100
2023-507649-27-00Phase 3OesophagectomyAuthorised38
2023-505378-14-00Phase 3Major emergency abdominal surgeryAuthorised342
2024-512444-29-00Phase 3Kidney, liver, or kidney-pancreas transplantationAuthorised362
2023-510492-57-00Phase 2Heart transplantation in childrenAuthorised15
2024-518174-13-00Phase 3Liver transplantationAuthorised200

FAQ

  • What kinds of clinical trials are investigating Glycine? The trials are mostly interventional studies in hospital care. They focus on organ preservation, nutrition support, and surgical recovery.
  • Who can take part in these studies? The target groups include living kidney donors and recipients, children having heart transplantation, liver or kidney transplant patients, people on hemodialysis, and adults after major abdominal surgery or oesophagectomy.
  • What phases are the Glycine trials in? The trials listed are mainly Phase 2 and Phase 3 studies. These phases usually look at safety, early benefit, and how well a treatment works in a larger group.
  • What are the main outcomes being measured? The studies measure outcomes such as renal function, muscle protein synthesis, infection rates, graft function, and liver injury markers like ALT or GPT. Some trials also track adverse events, which means unwanted medical problems during the study.
  • Are these trials all about the same condition? No. They cover several different conditions, including transplantation, surgical nutrition, and heart surgery in children. The common theme is testing hospital treatments that may improve recovery and organ protection.

Ongoing Clinical Trials on Glycine

  • Study comparing Custodiol-N and Custodiol organ preservation solutions for heart transplantation in children

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Organ Preservation in Kidney, Liver, and Pancreas Transplants Using Custodiol-N Solution Compared to a Drug Combination for Transplant Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study of Intradialytic Parenteral Nutrition for Muscle Protein Production in Patients on Long-term Hemodialysis Treatment

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study Comparing Custodiol-N and Custodiol for Heart Surgery in Children with Congenital Heart Defects

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Nutrition Methods and Muscle Loss After Esophagectomy Using SmofKabiven and Drug Combination for Patients Recovering from Esophageal Surgery

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Liver Transplantation: Comparing Custodiol-N Solution with a Drug Combination for Organ Preservation in Patients Undergoing Liver Transplant Surgery

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, helpful, or both.
  • Interventional study: A trial where researchers give a treatment or compare treatments to see what happens.
  • Phase 2: An early-to-mid stage trial that looks closely at safety and signs that a treatment may work.
  • Phase 3: A larger study that compares treatments in more people to confirm benefit and safety.
  • Renal function: How well the kidneys are working.
  • Renal reserve: How much extra kidney function is available when the kidneys are stressed or tested.
  • Myofibrillar fractional synthetic rate: A measure of how fast muscle protein is being made.
  • Cardioplegia: A method used during heart surgery to protect the heart muscle while the heart is stopped.
  • Graft function: How well a transplanted organ is working after surgery.
  • ALT / GPT: A blood test that can show liver injury or stress.
  • Adverse events: Unwanted medical problems or side effects that happen during a study.
  • AUC: Area under the curve, a way to measure a test result over time.

References

  1. https://clinicaltrials.gov/study/2024-519757-11-00
  2. https://clinicaltrials.gov/study/2025-522111-42-02
  3. https://clinicaltrials.gov/study/2024-511517-38-00
  4. https://clinicaltrials.gov/study/2023-507649-27-00
  5. https://clinicaltrials.gov/study/2023-505378-14-00
  6. https://clinicaltrials.gov/study/2024-512444-29-00
  7. https://clinicaltrials.gov/study/2023-510492-57-00
  8. https://clinicaltrials.gov/study/2024-518174-13-00