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NCT Number: NCT06929637

Amino Acid Infusion in Kidney Transplant Recipients

The study addresses the impact of amino acid infusion in the early post-transplant period on graft function and the incidence of post-transplant complications.

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Key information

Conditions

Short-term Graft Function Adverse Events Delayed Graft Function Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immunological &Amp; Inflammatory Markers Metabolic Diseases Metabolic Effects Nutritional Effect Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Safety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Martin

Martin, Slovakia, 03601

About this study

Background and Rationale: Delayed graft function (DGF) remains a significant challenge in kidney transplantation, particularly in recipients of deceased donor organs. DGF, often defined as the need for dialysis within the first post-transplant week, is associated with poorer long-term graft survival and increased immunological risk. Ischemia-reperfusion injury (IRI) plays a crucial role in the pathogenesis of DGF, contributing to oxidative stress, inflammation, and endothelial dysfunction. Strategies to mitigate IRI and enhance early graft recovery are highly sought after.

Amino acids play a critical role in cellular metabolism, protein synthesis, and immunomodulation. Prior research suggests that amino acid supplementation may improve nitrogen balance, enhance mitochondrial function, and reduce oxidative stress, potentially benefiting graft recovery. However, there is limited clinical evidence assessing whether perioperative amino acid administration improves graft function in kidney transplant recipients. The AID-KT study aims to evaluate the impact of intravenous amino acid infusion on early graft function following kidney transplantation.

Study Design: AID-KT is a prospective, interventional cohort study with a retrospective control group. The intervention group will receive intravenous amino acid (AA) supplementation at a dose of 1g/kg body weight daily for three days post-transplant. The historical control group consists of kidney transplant recipients from previous years who did not receive amino acid infusion. The study will evaluate graft function, metabolic response, and patient outcomes over a 12-month follow-up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years) undergoing deceased or living donor kidney transplantation
  • First-time kidney transplant recipients
  • No known allergy or contraindication to amino acids
  • Stable hemodynamic status post-transplant
  • Signed informed consent

Exclusion criteria

  • Patients requiring immediate dialysis post-transplant
  • Multi-organ transplant recipients
  • Severe hepatic dysfunction (Child-Pugh C)
  • Uncontrolled infection or sepsis
  • Malignancy within the past 5 years (except non-melanoma skin cancer)
  • Prior participation in conflicting clinical trials

Treatment and study plan

Infusion Therapy

Drug

Infusion of amino acids once daily - dose 1g/kg, maximum 100 g daily for 3 consecutive days starting D1 after kidney transplantation procedure

Saline solution infusion

Drug

Infusion of saline solution a s standard rehydration therapy after kidney transplantation

Primary outcomes

  1. Improving graft function 3 months after kidney transplantation

    Time frame: 90 days after enrollment/kidney transplantation

    Investigators assume infusion of amino acids will improve eGFR in the intervals: 7 days / 14 days / 30 days / 90 days after kidney transplantation.

Secondary outcomes

  1. Decrease of the biopsy proven acute rejection incidence

    Time frame: 90 days after enrollment

    Investigators assume the infusion of amino acids will decrease the incidence of biopsy proven acute rejection in 3rd month after kidney transplantation

  2. Improving levels of total proteins and albumin

    Time frame: 90 days after enrollment/kidney transplantation

    Investigators assume infusion amino acids will improve levels of total proteins and albumin.

  3. Lipid profile improvement

    Time frame: 90 days after enrollment/kidney transplantation

    Investigators assume infusion amino acids will improve levels of total cholesterol, triacyglycerides and LDL-cholesterol.

  4. Decreasing the incidence of delayed graft function

    Time frame: 7 days after enrollment / kidney transplantation

    Investigators assume the infusion of amino acids will decrease the incidence of DGF defined as a need for hemodialysis first week (7 days) after kidney transplantation.

  5. Monitoring the incidence of severe hyperkalemia

    Time frame: 90 days after enrollment/kidney transplantation

    Investigators will compare the safety of infusion if amino acids reflected by the incidence of hyperkalemia > 6.5 mmol/l

  6. Monitoring the incidence of metabolic acidosis

    Time frame: 90 days after enrollment/kidney transplantation

    Investigators will compare the safety of infusion if amino acids reflected by the incidence of metabolic acidosis - serum bicarbonate levels < 20 mmol/l

  7. Monitoring the incidence of elevated liver enzymes

    Time frame: 90 days after enrollment/kidney transplantation

    Investigators will compare the safety of infusion if amino acids with the incidence of increased levels of liver enzymes (AST, ALT, ALP, GMT) > 2x Upper Limit of Normal increased levels of total and conjugated bilirubin > 2x Upper Limit of Normal

  8. Monitoring the incidence of elevated bilirubin

    Time frame: 90 days after enrollment/kidney transplantation

    Investigators will compare the safety of infusion if amino acids with the incidence of increased levels of total and conjugated bilirubin > 2x Upper Limit of Normal.

Study contacts

Contact information is provided by the study sponsor or research team.

Matej Vnučák, assoc.prof., MD, PhD.

CONTACT

[email protected]

+421434203795

Sponsors and collaborators

Lead sponsor

University Hospital, Martin

Other

Registry information

Official study title

The Effect of Amino Acid Infusion on Early Graft Function After Kidney Transplantation

Acronym: AID-KT

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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