Observational Cohort Study Renal Transplantation University Hospitals Leuven

April 29, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

An Integrative Clinicopathological Decision Support System for Kidney Transplant Rejection

This observational cohort study aims to compile routinely collected clinical, histological and outcome data of kidney transplant recipients, to evaluate risk factors for post-transplant injury, phenotypes of injury, and impact on outcome of such injury, in order to provide clinicians more accurate, less biased and faster tools for diagnosis, clinical management and treatment decisions with regard to kidney transplant rejection.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The following data/features are collected prospectively and structured in the electronic medical records:

Demographics:

  • Date of transplantation
  • Date of graft failure
  • Last date of follow-up
  • Time after transplantation of survival (number of days);
  • kidney survival;
  • recipient death;
  • recipient gender;
  • recipient age at time of transplantation;
  • recipient weight at time of transplantation;
  • recipient BMI at time of transplantation;
  • recipient race;
  • recipient diabetes prior to transplantation;
  • the Belgian Index for Multiple Deprivation (BIMD);
  • combined vs single transplant (we included only single transplants);
  • repeat transplant vs. first transplant;
  • diagnosis of the original kidney disease (prior to transplantation);
  • donor type (living vs. deceased);
  • donor gender;
  • donor age in years;
  • donor diabetes yes vs no;
  • HLA genotype of donors and recipients, number of HLA A mismatches between donor and recipient (0-2); number of HLA B mismatches between donor and recipient (0-2); number of HLA DR mismatches between donor and recipient (0-2); number of total HLA mismatches between donor and recipient (0-6); high-resolution genotyping of donors and recipients HLA genes (11 loci);
  • cold ischemia time
  • warm ischemia time
  • operation time

Graft functional data:

  • Serum creatinine values from day of transplantation onwards;
  • Proteinuria values from day of transplantation onwards

Data on DSA:

DSA data collected in clinical routine, from the day of listing for transplantation onwards (clinically measured at the Histocompatibility laboratory of the Red Cross, Motstraat, Mechelen, and reported in the clinical patient records).

Biopsy data:

Both clinically indicated and protocol biopsies were performed in this cohort. On average, 3.2 biopsies per patient.

  • The following data are collected from the clinical records and transferred to a pseudonymized database: Date of the kidney biopsy; Indication biopsy = at time of graft dysfunction; protocol = prespecified biopsy per protocol; pretransplant = biopsy prior to transplantation (in the donor); post-transplant = biopsy after transplantation; time point (indication vs. Protocol biopsy time points); tubulitis (0-3); interstitial inflammation (0-3); vasculitis (0-3); glomerulitis (0-3); peritubular capillaritis (0-3); thrombi (0-3); C4d deposition in peritubular capillaries (0-3); C4d deposition in glomerular capillaries (0-3); transplant glomerulopathy (0-3); interstitial fibrosis (0-3); tubular atrophy (0-3); vascular intimal thickening (0-3); mesangial matrix increase (0-3); arteriolar hyalinosis (0-3); glomerulosclerosis (%); microcirculatory inflammation (0-6) = g + ptc; diagnosis of antibody-mediated rejection yes vs no according to current international consensus, calculated from g, ptc, cg, thrombi, C4d_ptc and v; diagnosis of T-cell mediated rejection yes vs no according to current international consensus (0 = absent, 1 = borderline; 1=present); diagnosis of IFTA grade (0-3) according to current international consensus: calculated from ci and ct
  • Next to pseudonymized clinical data, also histological slides are retrieved from the biobank of the Department of Pathology of the University Hospitals Leuven and whole slide images made available for image analysis.

Study Type

Observational

Enrollment (Actual)

1891

Contacts and Locations

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

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

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

All renal allograft recipients transplanted at the University Hospitals Leuven between 01/03/2004 and 01/06/2022 are included in this study, without restrictions with regard to age, sex, underlying kidney disease etc.

Description

Inclusion Criteria:

* All adult kidney transplant recipients transplanted at the University Hospitals Leuven between 01/03/2004 and 01/06/2022, without restrictions with regard to age, sex, underlying kidney disease etc.

Exclusion Criteria:

* Patients with combined transplantations (e.g. heart + kidney, liver + kidney, lung + kidney)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kidney transplant failure
Time Frame: 2004 - 2022
Graft failure, recipient death
2004 - 2022

Secondary Outcome Measures

Outcome Measure
Time Frame
Kidney transplant rejection phenotypes
Time Frame: 2004 - 2022
2004 - 2022
Kidney transplant function
Time Frame: 2004 - 2022
2004 - 2022

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Maarten Naesens, MD PhD, Universitaire Ziekenhuizen KU Leuven

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)

March 1, 2004

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S64006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data can only be made available to other researchers with a dedicated data transfer agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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