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

University Hospital, Martin

Status: Not yet enrolling

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

Treatments: Drug: Saline solution infusion; Drug: Infusion Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06929637

TNO_UNM_3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Aminoacid infusion

Active Comparator group

Description:

Infusion of amino acids,1 g/kg, maximum of 100g AA a day.

Treatment:

Drug: Infusion Therapy

Placebo arm

Placebo Comparator group

Description:

Infusion of saline solution

Treatment:

Drug: Saline solution infusion