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Arginine

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.

Table of contents

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.[1][2] 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.[1][3]

Several trials are authorised, while one trial is suspended.[1][4] 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.[1][5]

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.[1] The main endpoint is the area under the curve (AUC) of GPT, also called ALT, during the first 7 days after transplantation.[1] 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.[2] 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.[2] The key outcomes are delayed graft function for kidney transplants and AUC of GPT (ALT) for liver transplants.[2]

Children’s heart studies

One Phase 2 trial studies organ perfusion in 15 children undergoing heart transplantation.[3] It compares Custodiol-N with Custodiol and focuses on safety, with continuous reporting of adverse events for up to 3 months.[3]

Another Phase 2 study includes 100 children with congenital heart malformation who need cardiac surgery.[4] It compares two methods of cardioplegia, which means a controlled way to protect the heart during surgery.[4] 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.[4]

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.[5] The main endpoint is the difference in myofibrillar fractional synthetic rate during one week of treatment compared with control.[5] 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.[6] It measures the change in muscle size on CT scan from before surgery to 10 days after the operation.[6]

A further Phase 3 study in 342 patients after major emergency abdominal surgery compares early versus postponed supplementary parenteral nutrition.[7] Its main outcome is the rate of infectious complications during the hospital stay.[7]

Main endpoints and what they mean

The trials use different endpoints, which are the main results researchers want to measure.[1] 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.[1][2]

In the pediatric heart studies, the endpoints focus on safety and heart muscle protection, using adverse event reports and CK-MB blood levels.[3][4] In the nutrition studies, the endpoints look at muscle protein synthesis, muscle size, and infections after surgery.[5][6][7]

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.[1][2][3][4][5][6][7] Some studies are designed for children, while others are for adults only.[3][4][5]

Trial phases and status

Most of the trials listed are authorised, meaning they have been approved to proceed.[1][2][3][5][6][7] One study is suspended, which means it is temporarily stopped.[4]

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

Trial IDPhaseCondition studiedStatusEnrollment
2024-518174-13-00Phase 3Liver transplantationAuthorised200
2024-512444-29-00Phase 3Kidney, liver, or kidney-pancreatic transplantationAuthorised362
2023-510492-57-00Phase 2Heart transplantation in childrenAuthorised15
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

FAQ

  • What are the clinical trials about Arginine studying? The trials are studying hospital treatments such as organ preservation, heart surgery support, and nutrition support. They measure outcomes like safety, graft function, muscle protein changes, and infection rates.
  • Who can take part in these trials? The target groups include children having heart transplantation or heart surgery, adults having kidney, liver, or pancreas transplantation, people on hemodialysis, and patients after major emergency abdominal surgery or oesophagectomy.
  • What trial phases are included? Most studies are Phase 2 or Phase 3 trials. Phase 2 trials focus more on safety, while Phase 3 trials compare how well the study treatments work in larger groups.
  • What outcomes are the trials measuring? The trials measure outcomes such as adverse events, liver enzyme changes, delayed graft function, CK-MB levels, muscle size, muscle protein synthesis, and infectious complications. These help show whether the treatment is safe and useful.
  • Are all the trials completed? No. The trial statuses include Authorised and Suspended. This means some studies are active or approved, while at least one study is not currently moving forward.

Ongoing Clinical Trials on Arginine

  • 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 a medical treatment or procedure and measures specific results.
  • Phase 2: An early study phase that often focuses on safety and early signs of benefit.
  • Phase 3: A later study phase that compares treatments in larger groups to see how well they work.
  • Interventional study: A study where researchers give a treatment or procedure and then measure its effects.
  • Organ preservation: Keeping an organ in good condition before transplant so it can work after surgery.
  • Graft function: How well a transplanted organ works after surgery.
  • Delayed graft function: When a transplanted organ does not start working right away.
  • Adverse events: Unwanted medical problems that happen during a study.
  • Area under the curve (AUC): A way to measure a test value over time, not just at one single moment.
  • CK-MB: A blood test used to help check for heart muscle injury.
  • Muscle protein turnover: The process of making and breaking down muscle protein.
  • Hemodialysis: A treatment that filters the blood when the kidneys do not work well.

References

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