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Histidine

Clinical trials investigating Histidine are studying organ preservation and related treatments in transplant and surgery settings. The trials look at safety, graft function, and other outcomes in children and adults with kidney, liver, heart, pancreas, and abdominal surgery needs.

Table of Contents

Trial overview

The clinical trials listed for Histidine are mainly testing organ preservation and related treatment strategies in surgery and transplantation settings.[1][2][3][4][5][6]

Most of the studies are interventional, which means the researchers assign one treatment or another and then compare the results.[1][2][3][4][5][6]

The trial list includes both Phase 2 and Phase 3 studies, so the research ranges from smaller safety-focused studies to larger comparison studies.[1][2][3][4][5][6]

Transplant studies

Three trials focus on organ preservation with Custodiol-N compared with Custodiol in transplantation.[1][2][6]

One Phase 3 study includes people having kidney, liver, or kidney-pancreas transplantation and aims to show that Custodiol-N is not worse than Custodiol for graft preservation after surgery.[1]

Another Phase 3 study is in liver transplantation and measures GPT, also called ALT, over the first 7 days after transplant to assess liver injury and transplant success.[6]

These transplant studies are authorised and involve adult patients undergoing major transplant surgery.[1][6]

Paediatric heart studies

Two trials focus on children having heart-related surgery.[2][3]

One Phase 2 study compares Custodiol-N with Custodiol in children undergoing heart transplantation and mainly checks safety by tracking adverse events for up to 3 months.[2]

Another Phase 2 study in children with congenital heart malformation compares two cardioplegia methods, which are ways to protect the heart during surgery.[3]

That study is suspended and measures safety through adverse event reporting up to 30 days after surgery, along with myocardial protection using CK-MB levels.[3]

Nutrition and surgery studies

Two other Phase 3 trials study nutrition after major surgery rather than transplantation.[4][5]

One trial looks at route of nutrition after oesophagectomy, which is surgery to remove the oesophagus, and measures muscle size by CT scan from before surgery to 10 days after surgery.[4]

The other trial compares early versus postponed supplementary parenteral nutrition after major emergency abdominal surgery and measures whether infections during the hospital stay are reduced.[5]

These studies help researchers understand whether different feeding strategies affect recovery after major operations.[4][5]

Study design and participants

The trials use a randomized design, which means treatment is assigned by chance, and several are single blind, meaning one side does not know which treatment was given.[1][2][3]

They are also multicentre studies, so they are run at more than one hospital or clinic.[1][2][3]

The participant groups differ by study: some trials include children, while others include adults with kidney, liver, pancreas, oesophageal, or abdominal surgical conditions.[1][2][3][4][5][6]

Enrollment ranges from 15 participants in the small paediatric heart transplant study to 362 in the largest transplant comparison study.[1][2][3][4][5][6]

Outcomes being measured

The main outcomes in these trials are focused on safety and recovery after surgery.[1][2][3][4][5][6]

  • Safety assessment: one paediatric heart transplant study records adverse events for up to 3 months, and another paediatric heart surgery study tracks them for 30 days after surgery.[2][3]

  • Delayed graft function: the kidney transplant study uses this as its main endpoint, meaning it checks whether the new kidney starts working right away.[1]

  • Liver injury markers: the liver transplant study measures GPT (ALT) over 7 days, using the area under the curve, which shows how the value changes over time.[1][6]

  • Myocardial protection: the paediatric cardiac surgery study measures CK-MB levels to see how well the heart muscle is protected during surgery.[3]

  • Muscle size and infectious complications: the nutrition studies look at muscle loss after oesophagectomy and infection risk after emergency abdominal surgery.[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
2024-511517-38-00 Phase 2 Congenital heart malformation in children Suspended 100
2023-507649-27-00 Phase 3 Oesophagectomy Authorised 38
2023-505378-14-00 Phase 3 Major emergency abdominal surgery Authorised 342
2024-518174-13-00 Phase 3 Liver transplantation Authorised 200

FAQ

  • What are the Histidine trials mainly studying? The trials are mainly comparing organ preservation solutions in transplant surgery and heart surgery in children. They also include studies on nutrition after major surgery.
  • Who can take part in these trials? The target groups include children having heart transplantation or heart surgery for congenital heart malformation, and adults having kidney, liver, or kidney-pancreas transplantation. Other studies include people after oesophagectomy or major emergency abdominal surgery.
  • What trial phases are being used? The trials include Phase 2 and Phase 3 studies. Phase 2 trials mainly focus on safety, while Phase 3 trials look at larger comparisons and whether one approach works as well as or better than another.
  • What outcomes are measured in these trials? The trials measure safety, delayed graft function, liver injury markers, muscle size, and infection rates. Some studies also measure CK-MB, which is a heart muscle marker, and GPT (ALT), a liver enzyme used to check liver injury.
  • Are all the studies active right now? No. Most listed trials are authorised, but one paediatric heart surgery study is suspended. The trial status shows whether a study is allowed to run, paused, or stopped.

Ongoing Clinical Trials on Histidine

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

    Recruiting

    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

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

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

    Not yet recruiting

    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

    1 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

    1 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

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Organ transplantation: A surgery where a damaged organ is replaced with a healthy donor organ, such as a kidney, liver, heart, or pancreas.
  • Organ preservation: The process of keeping an organ in good condition before it is transplanted.
  • Phase 2: An early clinical trial phase that often focuses on safety and how well a treatment works in a smaller group.
  • Phase 3: A later trial phase with more participants that compares treatments and checks whether results are reliable.
  • Randomized: Participants are assigned by chance to different treatment groups.
  • Single blind: A study design where one side, usually the participant, does not know which treatment is being given.
  • Multicentre: A study carried out in more than one hospital or clinic.
  • Delayed graft function: When a transplanted kidney does not start working right away.
  • GPT (ALT): A liver enzyme measured in blood. Higher levels can show liver injury.
  • CK-MB: A marker in blood that can reflect injury to heart muscle.
  • Adverse events: Unwanted medical problems or side effects that happen during a study.
  • AUC: Short for area under the curve. It is a way to measure how a value changes over time.

References

  1. https://clinicaltrials.gov/study/2024-512444-29-00
  2. https://clinicaltrials.gov/study/2023-510492-57-00
  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/2024-518174-13-00