#1 Clinical Trials Search in Europe

Aspartic Acid

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.

Table of contents

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

These studies are being done in transplantation, pediatric heart surgery, and hemodialysis, with both Phase 2 and Phase 3 trials reported.[1][2][3][4][5]

Transplant studies and organ preservation

Three trials are focused on organ preservation, which means keeping an organ in good condition before it is transplanted.[1][5]

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.[1]

Another Phase 3 liver transplantation study compares Custodiol-N with Custodiol and measures liver test results after surgery over 7 days.[5]

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.[1][5]

Pediatric heart studies

Two studies involve children having heart-related surgery.[2][4]

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.[2]

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.[4]

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.[4]

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.[3]

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.[3]

This is a small authorised study with 20 participants and a one-week treatment period compared with control.[3]

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

  • Kidney transplant outcome: delayed graft function, which means the new kidney does not start working right away.[1]
  • 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.[1][5]
  • Pediatric heart transplant safety: continuous adverse event reporting for up to 3 months.[2]
  • Cardiac surgery safety and protection: adverse events up to 30 days after surgery and CK-MB levels up to day 7 or discharge.[4]
  • Hemodialysis outcome: difference in myofibrillar fractional synthetic rate during one week of treatment versus control.[3]

Study status and enrollment

Most of the trials are authorised, while one pediatric cardiac surgery study is suspended.[1][2][3][4][5]

Enrollment ranges from 15 participants in the smallest pediatric heart transplantation study to 362 participants in the largest transplant study.[1][2][3][4][5]

Overall, the trials show a research program centered on transplant support, surgical protection, and post-treatment recovery measures in children and adults.[1][2][3][4][5]

Trial ID Phase Condition studied Status Enrollment
2024-512444-29-00 Phase 3 Kidney, liver, and kidney-pancreas transplantation Authorised 362
2023-510492-57-00 Phase 2 Heart transplantation in children Authorised 15
2025-522111-42-02 Phase 3 Muscle protein turnover, hemodialysis Authorised 20
2024-511517-38-00 Phase 2 Congenital heart malformation in children Suspended 100
2024-518174-13-00 Phase 3 Liver transplantation Authorised 200

FAQ

  • What are the Aspartic Acid trials studying? The trials are mainly comparing organ preservation solutions in transplantation and cardiac surgery. One study also looks at muscle protein turnover in chronic hemodialysis patients.
  • Who can take part in these studies? The target groups include children having heart transplantation, children with congenital heart malformation having cardiac surgery, adults having kidney, liver, or kidney-pancreas transplantation, and chronic hemodialysis patients.
  • What trial phases are listed? The studies are in Phase 2 and Phase 3. Phase 2 studies usually focus more on safety, while Phase 3 studies compare treatments in larger groups.
  • What outcomes are being measured? The trials measure safety, delayed graft function, liver injury markers, myocardial protection, and muscle protein synthesis. Some studies use blood test results over time as the main endpoint.
  • Are all the trials active? No. Some trials are authorised, one is suspended, and all are interventional studies. This means the researchers are giving a treatment and tracking results.

Ongoing Clinical Trials on Aspartic Acid

  • 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 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

  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the results.
  • Phase 2: A mid-stage clinical trial that often focuses on safety and early signs of benefit.
  • Phase 3: A later-stage trial that compares treatments in larger groups to see how well they work and how safe they are.
  • Organ preservation: Keeping an organ in good condition before it is transplanted into a patient.
  • Graft function: How well the transplanted organ works after surgery.
  • Delayed graft function: When a transplanted kidney does not start working right away.
  • Area under the curve (AUC): A way to measure a test result over time, not just at one point.
  • GPT (ALT): A liver blood test used to check for liver injury or stress.
  • CK-MB: A blood marker that can help show heart muscle injury.
  • Myofibrillar fractional synthetic rate: A measure of how fast muscle protein is being made.
  • Hemodialysis: A treatment that cleans the blood when the kidneys do not work well.

References

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