Amino Acid Infusion in Kidney Transplant Recipients

NCT ID: NCT06929637

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2029-01-01

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Aminoacid infusion

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

Group Type: ACTIVE_COMPARATOR

Infusion Therapy

Intervention Type: DRUG

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

Placebo arm

Infusion of saline solution

Group Type: PLACEBO_COMPARATOR

Saline solution infusion

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Saline solution infusion

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Martin

OTHER

Sponsor Role: lead

Responsible Party

Matej Vnucak

deputy head of Transplant-Nephrology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Martin

Martin, Slovakia, Slovakia

Countries

Slovakia

Central Contacts

Matej Vnučák, assoc.prof., MD, PhD.

Role: CONTACT

matej.vnucak@unm.sk

+421434203795

Other Identifiers

TNO_UNM_3

Identifier Type: -

Identifier Source: org_study_id