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

NCT ID: NCT06130046

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2026-12-01

Brief Summary

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.

Detailed Description

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.

Conditions

Kidney Transplant; Complications; Liver Transplant; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

OLT

Observation of MR-proADM levels at protocol timepoints to predict main (DGF and AR) and secondary (surgical complications, infections, others) complications after liver transplantation at our Institution.

MR-proADM dosage

Intervention Type: BIOLOGICAL

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

KT

Observation of MR-proADM levels at protocol timepoints to predict main (DGF and AR) and secondary (surgical complications, urological complications, infections, others) complications after kidney transplantation at our Institution.

MR-proADM dosage

Intervention Type: BIOLOGICAL

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

Interventions

MR-proADM dosage

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rome Tor Vergata

OTHER

Sponsor Role: lead

Responsible Party

Roberta Angelico

Associate Professor, MD, PhD, FEBS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberta Angelico, PhD FEBS

Role: PRINCIPAL_INVESTIGATOR

University of Rome Tor Vergata

Locations

University of Rome Tor Vergata

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberta Angelico, PhD FEBS

Role: CONTACT

roberta.angelico@med.uniroma2.it

0620908294

Domiziana Pedini, MD

Role: CONTACT

domiziana.pedini@libero.it

+393488869569

References

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Other Identifiers

DARE

Identifier Type: -

Identifier Source: org_study_id