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Histidine Hydrochloride Monohydrate

This article examines two clinical trials involving the use of histidine hydrochloride monohydrate. The first trial investigates anifrolumab, which contains histidine hydrochloride monohydrate, for treating moderate to severe systemic lupus erythematosus in children and adolescents. The second trial compares Custodiol-N and Custodiol solutions, both containing histidine hydrochloride monohydrate, for organ preservation in liver transplantation.

Table of Contents

What is Histidine Hydrochloride Monohydrate?

Histidine hydrochloride monohydrate is a chemical compound that plays a crucial role in organ preservation solutions used during transplantation procedures[1]. It is a form of the amino acid histidine, which is essential for various biological processes in the human body.

Role in Organ Preservation Solutions

In organ transplantation, preserving the organ’s viability during transportation from the donor to the recipient is critical. Histidine hydrochloride monohydrate is a key component in preservation solutions because it helps maintain the organ’s cellular function and reduces damage caused by lack of oxygen (ischemia) during storage[1].

Custodiol Solution

Custodiol is a widely used organ preservation solution that contains histidine hydrochloride monohydrate as one of its active ingredients[2]. This solution is designed to protect organs, particularly the heart and liver, during the transplantation process. Other components of Custodiol include:

  • Mannitol
  • Histidine
  • Tryptophan
  • Magnesium chloride hexahydrate
  • Potassium chloride
  • Sodium chloride
  • Calcium chloride dihydrate
  • Oxogluric acid (also known as ketoglutaric acid)

Custodiol-N Solution

Custodiol-N is a newer formulation of the organ preservation solution, which is currently being studied for its potential benefits in liver transplantation[2]. While the exact composition of Custodiol-N is not provided in the available information, it is likely to contain histidine hydrochloride monohydrate as well, given its importance in organ preservation.

Use in Liver Transplantation

Histidine hydrochloride monohydrate, as part of organ preservation solutions like Custodiol and Custodiol-N, plays a crucial role in liver transplantation. These solutions are used to:

  • Flush the donor liver to remove blood
  • Protect the liver during cold storage and transportation
  • Maintain cellular function and reduce damage caused by lack of oxygen
  • Improve the chances of successful transplantation

Potential Benefits

The use of organ preservation solutions containing histidine hydrochloride monohydrate may offer several benefits in liver transplantation:

  • Improved organ function after transplantation
  • Reduced risk of initial poor function or delayed graft function
  • Potentially better outcomes for patients receiving liver transplants
  • Possibility of using organs from extended criteria donors (ECD) or donation after circulatory death (DCD) donors

Ongoing Research

A clinical trial is currently underway to compare the effectiveness of Custodiol-N with standard Custodiol solution in liver transplantation[2]. This study aims to evaluate:

  • The function of the transplanted liver using various blood tests
  • The occurrence of complications after transplantation
  • The effectiveness of these solutions in preserving livers from extended criteria donors and donation after circulatory death donors
The results of this study may provide valuable insights into the role of histidine hydrochloride monohydrate and other components in organ preservation solutions, potentially leading to improved outcomes for liver transplant recipients.

Aspect Anifrolumab Trial Liver Transplantation Trial
Study Type Phase III, randomized, double-blind, placebo-controlled Phase III, prospective, randomized, single-blind, multicenter
Condition Moderate to severe active systemic lupus erythematosus Liver transplantation
Age Group 5 to <18 years ≥18 years
Primary Endpoint BICLA response at Week 52 Area under the curve (AUC) GPT (ALT) after transplantation during 7 days
Study Duration 52 weeks + 52-week open-label extension 6 months follow-up
Key Inclusion Criteria SLE diagnosis, autoantibody positive, SLEDAI-2K ≥6 First-time liver transplant recipients
Key Exclusion Criteria Severe neuropsychiatric SLE, severe nephritis Pregnant or lactating patients, high urgency patients

FAQ

  • What is the main purpose of the anifrolumab trial? The main purpose is to determine the appropriate dose of anifrolumab for children and adolescents with moderate to severe lupus, and to confirm its safety and effectiveness in this population.
  • What age group is included in the anifrolumab study? The study includes children and adolescents aged 5 to less than 18 years old with moderate to severe active systemic lupus erythematosus.
  • What is the primary objective of the liver transplantation trial? The primary objective is to evaluate the area under the curve (AUC) of GPT (ALT) after transplantation during the first 7 days, comparing Custodiol-N and Custodiol solutions for organ preservation.
  • Who is eligible for the liver transplantation study? Recipients awaiting their first liver transplant who are 18 years or older are eligible for the study.
  • How long does the liver transplantation study follow patients? The study follows patients for up to 6 months after liver transplantation, evaluating various liver function parameters at 3 months and 6 months post-transplant.

Ongoing Clinical Trials on Histidine Hydrochloride Monohydrate

  • 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 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

  • Systemic Lupus Erythematosus (SLE): A chronic autoimmune disease that can affect various parts of the body, including skin, joints, kidneys, brain, and other organs.
  • Anifrolumab: A medication being studied for the treatment of moderate to severe systemic lupus erythematosus.
  • SLEDAI-2K: Systemic Lupus Erythematosus Disease Activity Index 2000, a tool used to measure disease activity in lupus patients.
  • BILAG-2004: British Isles Lupus Assessment Group 2004 index, another tool used to assess disease activity in lupus patients.
  • Custodiol-N: An organ preservation solution being studied for use in liver transplantation.
  • Custodiol: A standard organ preservation solution used in liver transplantation.
  • GPT (ALT): Glutamate Pyruvate Transaminase (Alanine Aminotransferase), an enzyme found primarily in the liver that is used as a marker of liver health.
  • LDH: Lactate Dehydrogenase, an enzyme found in many body tissues that can be elevated in various conditions, including liver damage.
  • INR: International Normalized Ratio, a measure of blood clotting time used to assess liver function.
  • Histidine Hydrochloride Monohydrate: A chemical compound used in various medical applications, including as a component in organ preservation solutions and some medications.

References

  1. http://clinicaltrials.eu/trial/study-of-anifrolumab-for-children-and-teens-with-moderate-to-severe-lupus/
  2. http://clinicaltrials.eu/trial/study-on-liver-transplantation-comparing-custodiol-n-solution-with-a-drug-combination-for-organ-preservation-in-patients-undergoing-liver-transplant-surgery/