Short-term Graft FunctionAID-KTNCT06929637
Amino Acid Infusion in Kidney Transplant Recipients
A study testing Infusion Therapy and Saline solution infusion in people with Short-term Graft Function and Metabolic Effects, run by University Hospital, Martin at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short-term Graft Function, Metabolic Effects, Nutritional Effect
- What is being tested?
- Infusion Therapy and Saline solution infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Sep 2025to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Amino Acid Infusion on Early Graft Function After Kidney Transplantation
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.
Read the 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
- Being tested
- Infusion Therapy, Saline solution infusion
- Keywords
- kidney transplantation, aminoacids, delayed graft function, diabetes mellitus, acute graft rejection, estimated glomerular filtration rate
- Medical subject headings
- Delayed Graft Function, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Saline solution infusionDrug
Infusion of saline solution a s standard rehydration therapy after kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| Aminoacid infusion | Active comparator | Infusion of amino acids,1 g/kg, maximum of 100g AA a day. Receives: Drug: Infusion Therapy |
| Placebo arm | Placebo comparator | Infusion of saline solution Receives: Drug: Saline solution infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after enrollment/kidney transplantation
Secondary outcomes (8)
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
Measured: 90 days after enrollment
Improving levels of total proteins and albumin
Investigators assume infusion amino acids will improve levels of total proteins and albumin.
Measured: 90 days after enrollment/kidney transplantation
Lipid profile improvement
Investigators assume infusion amino acids will improve levels of total cholesterol, triacyglycerides and LDL-cholesterol.
Measured: 90 days after enrollment/kidney transplantation
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.
Measured: 7 days after enrollment / kidney transplantation
Monitoring the incidence of severe hyperkalemia
Investigators will compare the safety of infusion if amino acids reflected by the incidence of hyperkalemia > 6.5 mmol/l
Measured: 90 days after enrollment/kidney transplantation
Monitoring the incidence of metabolic acidosis
Investigators will compare the safety of infusion if amino acids reflected by the incidence of metabolic acidosis - serum bicarbonate levels < 20 mmol/l
Measured: 90 days after enrollment/kidney transplantation
Monitoring the incidence of elevated liver enzymes
Investigators will compare the safety of infusion if amino acids with the incidence of increased levels of liver enzymes (AST, ALT, ALP, GMT) > 2x Upper Limit of Normal increased levels of total and conjugated bilirubin > 2x Upper Limit of Normal
Measured: 90 days after enrollment/kidney transplantation
Monitoring the incidence of elevated bilirubin
Investigators will compare the safety of infusion if amino acids with the incidence of increased levels of total and conjugated bilirubin > 2x Upper Limit of Normal.
Measured: 90 days after enrollment/kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short-term Graft FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Vnucak, University Hospital, Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929637
- Sponsor's protocol ID
- TNO_UNM_3
- Acronym
- AID-KT
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Amino Acid Infusion on Early Graft Function After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06929637
- Acronym / sponsor ID
- AID-KT / TNO_UNM_3
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminoacid infusion | Active comparator | Drug: Infusion TherapyInfusion of amino acids,1 g/kg, maximum of 100g AA a day. |
| Placebo arm | Placebo comparator | Drug: Saline solution infusionInfusion of saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion TherapyInfusion of amino acids once daily - dose 1g/kg, maximum 100 g daily for 3 consecutive days starting D1 after kidney transplantation procedure | Drug | Aminoacid infusion |
| Saline solution infusionInfusion of saline solution a s standard rehydration therapy after kidney transplantation | Drug | Placebo arm |
Primary outcome
Improving graft function 3 months after kidney transplantation
Time frame: 90 days after enrollment/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.
8 secondary outcomes
Decrease of the biopsy proven acute rejection incidence
Time frame: 90 days after enrollment
Improving levels of total proteins and albumin
Time frame: 90 days after enrollment/kidney transplantation
Lipid profile improvement
Time frame: 90 days after enrollment/kidney transplantation
Decreasing the incidence of delayed graft function
Time frame: 7 days after enrollment / kidney transplantation
Monitoring the incidence of severe hyperkalemia
Time frame: 90 days after enrollment/kidney transplantation
Monitoring the incidence of metabolic acidosis
Time frame: 90 days after enrollment/kidney transplantation
Monitoring the incidence of elevated liver enzymes
Time frame: 90 days after enrollment/kidney transplantation
Monitoring the incidence of elevated bilirubin
Time frame: 90 days after enrollment/kidney transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infusion Therapy and Saline solution infusion in people with Short-term Graft Function and Metabolic Effects, run by University Hospital, Martin at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matej Vnučák, assoc.prof., MD, PhD. (+421434203795, matej.vnucak@unm.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving graft function 3 months after kidney transplantation (time frame: 90 days after enrollment/kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.