NCT06929637

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Sep 2025Jan 2029

First Submitted

Initial submission to the registry

April 1, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

April 1, 2025

Last Update Submit

April 8, 2025

Conditions

Short-term Graft FunctionMetabolic EffectsNutritional EffectImmunological &Amp; Inflammatory MarkersSafetyAdverse Events

Keywords

kidney transplantationaminoacidsdelayed graft functiondiabetes mellitusacute graft rejectionestimated glomerular filtration rate

Outcome Measures

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.

    90 days after enrollment/kidney transplantation

Secondary Outcomes (8)

  • Decrease of the biopsy proven acute rejection incidence

    90 days after enrollment

  • Improving levels of total proteins and albumin

    90 days after enrollment/kidney transplantation

  • Lipid profile improvement

    90 days after enrollment/kidney transplantation

  • Decreasing the incidence of delayed graft function

    7 days after enrollment / kidney transplantation

  • Monitoring the incidence of severe hyperkalemia

    90 days after enrollment/kidney transplantation

  • +3 more secondary outcomes

Study Arms (2)

Aminoacid infusion

ACTIVE COMPARATOR

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

Drug: Infusion Therapy

Placebo arm

PLACEBO COMPARATOR

Infusion of saline solution

Drug: Saline solution infusion

Interventions

Infusion TherapyDRUG

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

Aminoacid infusion
Saline solution infusionDRUG

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

Placebo arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Martin

Martin, Slovakia, 03601, Slovakia

Location

MeSH Terms

Conditions

Delayed Graft FunctionDiabetes Mellitus

Interventions

Home Infusion Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsHome Care ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Matej Vnučák, assoc.prof., MD, PhD.

CONTACT

+421434203795matej.vnucak@unm.sk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy head of Transplant-Nephrology Department

Study Record Dates

First Submitted

April 1, 2025

First Posted

April 16, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

September 15, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

April 16, 2025

Record last verified: 2025-04

Locations

SL(1)