NCT06929637

Amino Acid Infusion in Kidney Transplant Recipients

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Martin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Short-term Graft Function
• Metabolic Effects
• Nutritional Effect
• Immunological &Amp; Inflammatory Markers
• Safety
• Adverse Events

Interventions

Type	Name	Description
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
DRUG	Saline solution infusion	Infusion of saline solution a s standard rehydration therapy after kidney transplantation

Timeline

• Start date: 2025-09-15
• Primary completion: 2028-09-15
• Completion: 2029-01-01
• First posted: 2025-04-16
• Last updated: 2025-04-16

Locations

1 site across 1 country: Slovakia