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NCT Number: NCT06130046

MR-proADM as a Early Biomarker for DGF and AR in Kidney and Liver Transplantation

To define the sensibility and the specificity of increased levels of MR-proADM for early, non-invasive, diagnosis of AR and DGF after kidney and liver transplantation creating a predictive model for related complications after kidney and liver transplantation based on the pre-operative and post-operative levels of MR-proADM and by a machine learning process.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rome Tor Vergata

Rome, 00133, Italy

Location status: Recruiting

About this study

Despite long-term outcomes of kidney and liver transplantation significantly improved in the last decades, high morbidity and mortality is still an issue at short term after transplantation. Specifically, occurrence of delayed graft function (DGF) and early acute rejection (AR) may cause multi-organ failure or graft failure, admission to intensive care unit, prolonged hospitalization and high-dosage immunosuppressive therapy which might expose patients to several further complications such as infections, neoplasm, and metabolic disease. Consequently, solid organ transplant recipients represent a very frail population at high risk of complications. Therefore, development of new biomarkers for the prevention and early diagnosis of the major post-transplant complications influencing the morbidity and mortality of solid organ transplant recipients are needed. Adrenomedullin (ADM) is a 52-amino acid peptide with a variety of physiologic functions such as immunemodulating activity, direct bactericidal activity, maintenance of renal homeostasis, and vasodilatory activity. Recent study has shown that midregional proADM (MR-proADM) is co-synthesized with ADM in equimolar amounts and has the advantages of a longer half-life, lack of bioactivity and lack of protein binding. MR-proADM has been recognized as a prognostic marker, stratifying the mortality risk in patients with sepsis in intensive care units. Moreover, recently MD-proADM has been also associated with risk of specific organ failure such as acute kidney injury, acute liver damage, acute respiratory distress syndrome and acute cardiac injury. Literature results suggest that recovery of graft function after KT may lead to decrease in plasma MR-proADM level in patients with ESRD, and that plasma MR-proADM level may could increase in the early phases of DGF and AR after KT and LT as a response damage and to the immune activation. The study will allow to evaluate the utility MR-proADM as an early biomarker of DGF and AR in patients undergoing kidney and liver transplantation at our Institution. Also, the study aims to analyze how the value of this biomarker can change in association with post-transplant complication and to create a predicting model by machine cut-off values of references for MR-proADM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Kidney transplant recipient at our Institution
  • Liver transplant recipient at our Institution

Exclusion criteria

  • Re-transplantation
  • Dual kidney transplantation
  • Combined transplant (kidney-liver, kidney-pancreas)
  • Autoimmune disease as indication to transplant

Treatment and study plan

MR-proADM dosage

Biological

Dosage of MR proADM at OLT/KT, 1, 3, 5, 15 POD and 1, 3, 6, 9, 12 months F-U

Primary outcomes

  1. Accuracy of MR-proADM as biomarker of DGF and AR in OLT/KT

    Time frame: 3 years

    To define the sensibility and the specificity of increased levels of MR-proADM for early, non-invasive, diagnosis of AR and DGF after kidney and liver transplantation.

Secondary outcomes

  1. Accuracy of MR-proAMD for early detection of other complications in OLT/KT

    Time frame: 3 years

    Creating a predictive model of complications after kidney and liver transplantation based on the pre-operative and post-operative levels of MR-proADM by machine learning process.

  2. Algorithm for risk prediction

    Time frame: 3 years

    Development of a software algorithm predicting the risk of post-transplant complications

  3. Digital Pathology Dataset

    Time frame: 3 years

    Development of digital pathology for graft biopsy

  4. MR-proADM Online Dataset

    Time frame: 3 years

    Development of an online platform to collect and correlate data on post-transplant biopsy and MRPro-ADM levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Domiziana Pedini, MD

CONTACT

[email protected]

+393488869569

Roberta Angelico, PhD FEBS

CONTACT

[email protected]

0620908294

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Acronym: DARE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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