Clinical trial NCT06929637: Amino Acid Infusion in Kidney Transplant Recipients
Official title: The Effect of Amino Acid Infusion on Early Graft Function After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Short-term Graft Function
Metabolic Effects
Nutritional Effect
Immunological &Amp; Inflammatory Markers
Safety
Adverse Events
Keywords: kidney transplantation
aminoacids
delayed graft function
diabetes mellitus
acute graft rejection
estimated glomerular filtration rate
Lead sponsor: University Hospital, Martin
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improving graft function 3 months after kidney transplantation
timeFrame: 90 days after enrollment/kidney transplantation
Secondary outcomes:
measure: Decrease of the biopsy proven acute rejection incidence
timeFrame: 90 days after enrollment
measure: Improving levels of total proteins and albumin
timeFrame: 90 days after enrollment/kidney transplantation
measure: Lipid profile improvement
timeFrame: 90 days after enrollment/kidney transplantation
measure: Decreasing the incidence of delayed graft function
timeFrame: 7 days after enrollment / kidney transplantation
measure: Monitoring the incidence of severe hyperkalemia
timeFrame: 90 days after enrollment/kidney transplantation
measure: Monitoring the incidence of metabolic acidosis
timeFrame: 90 days after enrollment/kidney transplantation
measure: Monitoring the incidence of elevated liver enzymes
timeFrame: 90 days after enrollment/kidney transplantation
measure: Monitoring the incidence of elevated bilirubin
timeFrame: 90 days after enrollment/kidney transplantation
Other outcomes:
Locations:
city: Martin
country: Slovakia
facility: University Hospital Martin
Study officials:
References: