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

NCT06130046 | Recruiting

• 1 other identifier: DARE
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications; Liver Transplant; Complications

Keywords

MR-proADM; Adrenomedullin; Kidney Transplantation; Liver Transplantation; DGF; Acute rejection

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

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

  3 years

• Algorithm for risk prediction

  3 years

• Digital Pathology Dataset

  3 years

• MR-proADM Online Dataset

  3 years

Study Arms (2)

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

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

Interventions

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

KT; OLT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

University of Rome Tor Vergata

Rome, 00133, Italy

RECRUITING

Related Publications (12)

• Legramante JM, Mastropasqua M, Susi B, Porzio O, Mazza M, Miranda Agrippino G, D Agostini C, Brandi A, Giovagnoli G, Di Lecce VN, Bernardini S, Minieri M. Prognostic performance of MR-pro-adrenomedullin in patients with community acquired pneumonia in the Emergency Department compared to clinical severity scores PSI and CURB. PLoS One. 2017 Nov 21;12(11):e0187702. doi: 10.1371/journal.pone.0187702. eCollection 2017.

  PMID: 29161297 BACKGROUND

• Minieri M, Di Lecce VN, Lia MS, Maurici M, Bernardini S, Legramante JM. Role of MR-proADM in the risk stratification of COVID-19 patients assessed at the triage of the Emergency Department. Crit Care. 2021 Nov 26;25(1):407. doi: 10.1186/s13054-021-03834-9. No abstract available.

  PMID: 34836547 BACKGROUND

• Manzia TM, Lai Q, Hartog H, Aijtink V, Pellicciaro M, Angelico R, Gazia C, Polak WG, Rossi M, Tisone G. Graft weight integration in the early allograft dysfunction formula improves the prediction of early graft loss after liver transplantation. Updates Surg. 2022 Aug;74(4):1307-1316. doi: 10.1007/s13304-022-01270-0. Epub 2022 Mar 19.

  PMID: 35306614 BACKGROUND

• Angelico R, Gerlach UA, Gunson BK, Neil D, Mergental H, Isaac J, Muiesan P, Mirza D, Perera MTP. Severe Unresolved Cholestasis Due to Unknown Etiology Leading to Early Allograft Failure Within the First 3 Months of Liver Transplantation. Transplantation. 2018 Aug;102(8):1307-1315. doi: 10.1097/TP.0000000000002139.

  PMID: 29470351 BACKGROUND

• Marutsuka K, Nawa Y, Asada Y, Hara S, Kitamura K, Eto T, Sumiyoshi A. Adrenomedullin and proadrenomudullin N-terminal 20 peptide (PAMP) are present in human colonic epithelia and exert an antimicrobial effect. Exp Physiol. 2001 Sep;86(5):543-5. doi: 10.1113/eph8602250.

  PMID: 11571480 BACKGROUND

• Minamino N, Kikumoto K, Isumi Y. Regulation of adrenomedullin expression and release. Microsc Res Tech. 2002 Apr 1;57(1):28-39. doi: 10.1002/jemt.10048.

  PMID: 11921354 BACKGROUND

• Kita T, Kitamura K. Translational studies of adrenomedullin and related peptides regarding cardiovascular diseases. Hypertens Res. 2022 Mar;45(3):389-400. doi: 10.1038/s41440-021-00806-y. Epub 2022 Jan 6.

  PMID: 34992239 BACKGROUND

• Ueda S, Nishio K, Minamino N, Kubo A, Akai Y, Kangawa K, Matsuo H, Fujimura Y, Yoshioka A, Masui K, Doi N, Murao Y, Miyamoto S. Increased plasma levels of adrenomedullin in patients with systemic inflammatory response syndrome. Am J Respir Crit Care Med. 1999 Jul;160(1):132-6. doi: 10.1164/ajrccm.160.1.9810006.

  PMID: 10390390 BACKGROUND

• Eto T, Kitamura K. Adrenomedullin and its role in renal diseases. Nephron. 2001 Oct;89(2):121-34. doi: 10.1159/000046059. No abstract available.

  PMID: 11549894 BACKGROUND

• Suzuki Y, Itoh H, Katagiri F, Sato F, Kawasaki K, Sato Y, Sato Y, Mimata H, Takeyama M. Relationship between plasma mid-regional pro-adrenomedullin level and resistance to antihypertensive therapy in stable kidney transplant recipients. Peptides. 2013 Oct;48:45-8. doi: 10.1016/j.peptides.2013.08.001. Epub 2013 Aug 13.

  PMID: 23954711 BACKGROUND

• Reuken PA, Kiehntopf M, Stallmach A, Bruns T. Mid-regional pro-adrenomedullin (MR-proADM): an even better prognostic biomarker than C-reactive protein to predict short-term survival in patients with decompensated cirrhosis at risk of infection? J Hepatol. 2012 Nov;57(5):1156-8; author reply 1158-9. doi: 10.1016/j.jhep.2012.06.036. Epub 2012 Aug 11. No abstract available.

  PMID: 22892248 BACKGROUND

• Valenzuela-Sanchez F, Valenzuela-Mendez B, Rodriguez-Gutierrez JF, Estella-Garcia A, Gonzalez-Garcia MA. New role of biomarkers: mid-regional pro-adrenomedullin, the biomarker of organ failure. Ann Transl Med. 2016 Sep;4(17):329. doi: 10.21037/atm.2016.08.65.

  PMID: 27713887 BACKGROUND

Biospecimen

Retention: NONE RETAINED

EDTA Blood Samples

Study Officials

• Roberta Angelico, PhD FEBS

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Angelico, PhD FEBS

CONTACT

0620908294; roberta.angelico@med.uniroma2.it

Domiziana Pedini, MD

CONTACT

+393488869569; domiziana.pedini@libero.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD, FEBS

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)