Amino Acid Infusion in Kidney Transplant Recipients (AID-KT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Safety; Adverse Events; Metabolic Effects; Short-term Graft Function; Nutritional Effect; Immunological &Amp; Inflammatory Markers
• Intervention / Treatment: Drug: Infusion Therapy; Drug: Saline solution infusion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matej Vnučák, assoc.prof., MD, PhD.; Phone Number: +421434203795; Email: matej.vnucak@unm.sk

Study Locations

• Slovakia
  • Martin, Slovakia, 03601
    • University hospital Martin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aminoacid infusion; Infusion of amino acids,1 g/kg, maximum of 100g AA a day.	Drug: Infusion Therapy; Infusion of amino acids once daily - dose 1g/kg, maximum 100 g daily for 3 consecutive days starting D1 after kidney transplantation procedure
Placebo Comparator: Placebo arm; Infusion of saline solution	Drug: Saline solution infusion; Infusion of saline solution a s standard rehydration therapy after kidney transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving graft function 3 months after 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.	90 days after enrollment/kidney transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease of the biopsy proven acute rejection incidence	Investigators assume the infusion of amino acids will decrease the incidence of biopsy proven acute rejection in 3rd month after kidney transplantation	90 days after enrollment
Improving levels of total proteins and albumin	Investigators assume infusion amino acids will improve levels of total proteins and albumin.	90 days after enrollment/kidney transplantation
Lipid profile improvement	Investigators assume infusion amino acids will improve levels of total cholesterol, triacyglycerides and LDL-cholesterol.	90 days after enrollment/kidney transplantation
Decreasing the incidence of delayed graft function	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.	7 days after enrollment / kidney transplantation
Monitoring the incidence of severe hyperkalemia	Investigators will compare the safety of infusion if amino acids reflected by the incidence of hyperkalemia > 6.5 mmol/l	90 days after enrollment/kidney transplantation
Monitoring the incidence of metabolic acidosis	Investigators will compare the safety of infusion if amino acids reflected by the incidence of metabolic acidosis - serum bicarbonate levels < 20 mmol/l	90 days after enrollment/kidney transplantation
Monitoring the incidence of elevated liver enzymes	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	90 days after enrollment/kidney transplantation
Monitoring the incidence of elevated bilirubin	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.	90 days after enrollment/kidney transplantation

Collaborators and Investigators

• Sponsor: University Hospital, Martin

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2025
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: kidney transplantation; estimated glomerular filtration rate; diabetes mellitus; delayed graft function; acute graft rejection; aminoacids
• Other Study ID Numbers: TNO_UNM_3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No