Amino Acid Infusion in Kidney Transplant Recipients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Martin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients requiring immediate dialysis post-transplant

Multi-organ transplant recipients

Severe hepatic dysfunction (Child-Pugh C)

Uncontrolled infection or sepsis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Infusion Therapy

    Drug

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

  • Saline solution infusion

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Aminoacid infusionActive comparator 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
90 days after enrollment/kidney transplantation

Secondary outcomes

1

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

Time frame
90 days after enrollment
2

Improving levels of total proteins and albumin

Investigators assume infusion amino acids will improve levels of total proteins and albumin.

Time frame
90 days after enrollment/kidney transplantation
3

Lipid profile improvement

Investigators assume infusion amino acids will improve levels of total cholesterol, triacyglycerides and LDL-cholesterol.

Time frame
90 days after enrollment/kidney transplantation
4

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.

Time frame
7 days after enrollment / kidney transplantation

Other outcomes

Sponsors and contacts

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