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

November 11, 2023 updated by: Roberta Angelico, University of Rome Tor Vergata
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Rome, Italy, 00133
        • Recruiting
        • University of Rome Tor Vergata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any adult kidney or liver transplant recipients who underwent OLT or KT at the University of Rome Tor Vergata with no indication for autoimmune diseases or for combined/dual transplant or re-transplantation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: MR-proADM dosage
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.
Biological: MR-proADM dosage
Dosage of MR proADM at OLT/KT, 1, 3, 5, 15 POD and 1, 3, 6, 9, 12 months F-U

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
Algorithm for risk prediction
Time Frame: 3 years
Development of a software algorithm predicting the risk of post-transplant complications
3 years
Digital Pathology Dataset
Time Frame: 3 years
Development of digital pathology for graft biopsy
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Investigators

  • Principal Investigator: Roberta Angelico, PhD FEBS, University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

November 11, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DARE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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