NCT05907434

Brief Summary

Renal failure is a common complication of lung transplant (LUTX) and orthotopic liver transplantation (OLTX). Early diagnosis of acute kidney injury (AKI) in this cohort is of utmost importance, since AKI after solid organ transplant is associated with worsened short and long-term outcomes. To now, early biomarkers of renal failure based on the measurement of cell-cycle arrest proteins have never been tested in this population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

June 8, 2023

Last Update Submit

March 4, 2025

Conditions

Acute Kidney Injury

Keywords

acute kidney injurybiomarkerslung transplantliver transplant

Outcome Measures

Primary Outcomes (1)

  • acute kidney injury

    according to KIDGO guidelines

    <7 days from transplant

Secondary Outcomes (1)

  • acute kidney disease

    < 90 days from transplant

Study Arms (2)

Lung transplant recipients

Adult undergoing primary non emergent lung transplant

Diagnostic Test: Nephrocheck (AKI score)

Liver transplant

Adult undergoing primary non emergent livertransplant

Diagnostic Test: Nephrocheck (AKI score)

Interventions

Nephrocheck (AKI score)DIAGNOSTIC_TEST

Early biomarker of AKI

Also known as: urinary biomarker [TIMP-2] × [IGFBP-7]
Liver transplantLung transplant recipients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult undergone primary double lung transplant or liver transplantation

You may qualify if:

  • Enlistment for bilateral LUTX
  • Enlistment for bilateral OLTX
  • Age \> 18 years
  • Signed informed consent

You may not qualify if:

  • Age \< 18 years old
  • Urgency enlistment
  • Already undergone solid organ transplant
  • Preoperative use of RRT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary and plasma biobanking

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

February 1, 2022

Primary Completion

December 31, 2024

Study Completion

March 1, 2025

Last Updated

March 7, 2025

Record last verified: 2025-03

Locations

IT(1)