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Magnesium

Clinical trials in this article investigate Magnesium-related study settings through organ preservation and heart surgery research. The trials compare Custodiol-N with Custodiol in patients having kidney, liver, pancreas, or heart procedures, including children. They mainly assess safety, graft function, and organ protection.

Table of contents

Trial overview

These studies are interventional trials, which means the research teams give study treatments and compare results between groups.[1][2][3][4]

The trials compare Custodiol-N with Custodiol in organ preservation or cardiac surgery settings.[1][2][3][4]

The source data do not describe Magnesium as the study drug in detail, but the article is based only on the trial records provided and their study settings.

Who is being studied

One Phase 3 study includes patients who will undergo kidney, liver, or kidney-pancreatic transplantation.[1]

Another Phase 3 study focuses on liver transplantation patients.[3]

A Phase 2 study is in children having heart transplantation.[2]

Another Phase 2 study is in children with congenital heart malformation, which means a heart problem present from birth.[4]

Study phases and design

Two trials are in Phase 3, which usually means a later stage of testing in a larger group of people.[1][3]

Two trials are in Phase 2, which usually looks closely at safety and early signs of benefit.[2][4]

Several trials are described as prospective and randomized, meaning they are planned in advance and assign treatments by chance to compare groups fairly.[1][2][4]

Some studies are also single blind, which means one side in the study does not know which treatment was given.[1][2][4]

What is being measured

The main outcome in the kidney part of the Phase 3 transplant study is delayed graft function, which means the transplanted kidney does not start working right away.[1]

In the liver transplant studies, the main outcome is the area under the curve (AUC) of GPT (ALT) over the first 7 days after transplantation.[1][3]

GPT (ALT) is a liver blood test, and the study uses repeated daily measurements to summarize liver injury over time.[3]

The pediatric heart transplantation study measures safety by tracking adverse events for up to 3 months.[2]

The pediatric congenital heart surgery study also measures safety through adverse event reporting, and it checks myocardial protection, which means protection of the heart muscle during surgery.[4]

In that study, heart muscle protection is assessed by CK-MB levels, a blood marker used during the postoperative period.[4]

Trial status and size

Three studies are currently authorised.[1][2][3]

One pediatric Phase 2 study is suspended.[4]

The planned enrollment ranges from 15 participants in the smallest pediatric heart transplant study to 362 participants in the largest transplant preservation study.[1][2]

What these trials mean for patients

These trials are mainly trying to find out whether Custodiol-N can match or improve the results of Custodiol in surgery and transplantation settings.[1][3]

For patients, the key questions are whether the transplanted organ works well, whether liver tests stay lower, and whether treatment is safe in the first days or months after surgery.[1][2][3][4]

The trial records show research focused on both adult transplant care and pediatric heart-related surgery, with outcomes chosen to reflect real recovery after the operation.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
2024-512444-29-00 Phase 3 Kidney, liver, and kidney-pancreatic transplantation Authorised 362
2023-510492-57-00 Phase 2 Heart transplantation in children Authorised 15
2024-518174-13-00 Phase 3 Liver transplantation Authorised 200
2024-511517-38-00 Phase 2 Congenital heart malformation in children Suspended 100

FAQ

  • What are the Magnesium clinical trials studying? The trials are studying organ preservation and heart surgery outcomes. They compare Custodiol-N with Custodiol in transplant and pediatric cardiac surgery settings.
  • Who can take part in these trials? The target groups include patients who will undergo kidney, liver, or kidney-pancreatic transplantation, children having heart transplantation, and children with congenital heart malformation having cardiac surgery.
  • What phases are these trials in? The trials are in Phase 2 and Phase 3. Phase 2 studies focus more on safety, while Phase 3 studies look at whether the new approach works as well as the comparison treatment.
  • What main outcomes are being measured? The studies measure safety, delayed graft function, liver injury markers such as GPT (ALT), and myocardial protection. Some trials also track adverse events over time.
  • Are all of these trials active? No. The data show some trials are authorised, while one pediatric heart surgery trial is suspended.

Ongoing Clinical Trials on Magnesium

  • 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 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

  • Clinical trial: A planned research study in people that tests whether a treatment or approach is safe and works as intended.
  • Interventional study: A study where participants receive a treatment or procedure so researchers can compare outcomes.
  • Phase 2: An early study phase that usually looks closely at safety and early signs of benefit.
  • Phase 3: A later study phase that compares treatments in larger groups to see how well they work and how safe they are.
  • Organ preservation: Steps used to keep an organ in good condition before transplantation.
  • Transplantation: A surgery in which a damaged organ is replaced with a healthy donor organ.
  • Graft function: How well the transplanted organ works after surgery.
  • Delayed graft function: When a transplanted kidney does not start working right away.
  • GPT (ALT): A liver enzyme measured in the blood; higher levels can suggest liver injury.
  • Area under the curve (AUC): A way to summarize repeated test results over time into one overall number.
  • Adverse events: Unwanted medical problems that happen during a study, whether or not they are caused by the treatment.
  • Myocardial protection: Protection of the heart muscle during surgery.

References

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