Evaluation of the Outcomes of Kidney Biopsies in Deceased Donors in the Emilia-Romagna Region (KT-BX-RER Stud)

November 6, 2026 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

The KT-BX-RER Study is a multicenter observational cohort study, with both retrospective and prospective components, designed to evaluate pre-implant kidney biopsies from deceased donors in the Emilia-Romagna Region and to compare findings between donors after circulatory death (DCD) and donors after brain death (DBD).

Chronic kidney disease affects 10-15% of the global population, and kidney transplantation is considered the most effective treatment for end-stage renal disease. Because the demand for donor organs exceeds their availability, the use of kidneys from DCD donors has increased. However, DCD donation is associated with prolonged warm ischemia time and ischemia-reperfusion injury, which may lead to thrombotic microangiopathy (TMA), acute tubular necrosis (ATN), delayed graft function (DGF), or primary non-function (PNF).

Kidney quality is currently assessed through pre-transplant biopsy using the Karpinski score. Since this score does not specifically evaluate TMA, the Emilia-Romagna Transplant Reference Center and Pathology Department integrated additional morphological parameters derived from the Banff classification, including assessment of TMA and ATN as indicators of ischemia-reperfusion injury.

The Emilia-Romagna Region has extensive experience with controlled DCD programs and represents a large proportion of Italian DCD activity. The study aims to provide evidence that may improve the interpretation of pre-implant biopsy findings and clarify the role of biopsy assessment in DCD kidney transplantation.

The primary objective is to determine whether there is a difference, and to what extent, in the presence of TMA and ATN in pre-implant kidney biopsies from DCD donors compared with DBD donors. Outcomes include presence, percentage, and severity (mild, moderate, severe) of TMA and ATN measured at the time of organ pre-implant assessment.

Secondary objectives include:

Comparing the prevalence of different ATN groups between DCD and DBD donors. Comparing epidemiological and transplant outcome data between DCD and DBD transplantation.

Evaluating whether the relationship between TMA and transplant outcomes is modified by donor type (DCD versus DBD).

Secondary outcome measures include:

Histological findings of pre-implant biopsies, including Karpinski score components.

Graft survival. Causes of graft loss. Recipient survival. Causes of death. Post-transplant complications. DGF and PNF. Post-transplant renal function assessed by estimated glomerular filtration rate (eGFR).

Study Design This is a retrospective and prospective multicenter cohort study involving transplant centers in Bologna, Parma, and Modena. All eligible DCD and DBD donors from Emilia-Romagna between 1 January 2017 and 31 December 2024 will be included retrospectively, while donors from 1 January 2025 to 31 December 2027 will be enrolled prospectively. Only kidneys from Emilia-Romagna donors whose biopsies were evaluated by the Pathology Department of the IRCCS Azienda Ospedaliero-Universitaria di Bologna will be included.

Kidney transplant recipients aged over 18 years who received kidneys from these donors will also be enrolled. Recipients transplanted through the national excess, highly immunized, or DECK allocation programs will be excluded. No additional treatments, examinations, or procedures beyond routine clinical practice are required.

Sample Size and Duration For the primary endpoint, the study assumes a TMA prevalence of 2% among DBD donors and 5% among DCD donors. A sample size of 1,677 subjects provides approximately 80% statistical power to detect this difference.

The overall study duration is nine years, consisting of:

36 months of enrollment, 60 months of follow-up, 12 months of data analysis. Data Collection and Analysis

Clinical data will be collected in pseudonymized form through an electronic case report form managed on the REDCap platform. Recipient follow-up will occur according to routine clinical practice, with assessments at 3, 6, 12, 24, and 36 months after transplantation. Variables include immunological characteristics, immunosuppressive therapy, DGF, PNF, creatinine levels, complications, and survival.

The primary analysis will use multiple logistic regression with TMA as the outcome and donor type (DCD versus DBD) as the exposure variable, adjusting for donor and recipient characteristics. Secondary analyses will use regression models, Cox proportional hazards models, competing-risk models, and mixed linear models, depending on the outcome evaluated. Effect modification by donor type in the association between TMA and transplant outcomes will also be assessed.

Ethical and Administrative Aspects Written informed consent will be obtained from transplant recipients. Because organ donors are deceased, consent cannot be obtained from them. For retrospective recipient data, consent will be sought during follow-up visits; under specific circumstances i

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

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Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
        • Principal Investigator:
          • Giuseppe Tarantino, MD
      • Modena, Italy, 41124
        • Not yet recruiting
        • AOU di Modena - Policlinico di Modena
        • Contact:
        • Principal Investigator:
          • Giacomo Mori, MD
      • Parma, Italy, 43126
        • Not yet recruiting
        • Azienda Ospedaliero - Universitaria di Parma
        • Contact:
        • Principal Investigator:
          • Umberto Maggiore, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of DCD and DBD donors from the Emilia Romagna Region from January 1, 2017, to December 31, 2024 (for the retrospective portion) and from January 1, 2025, to December 31, 2027, for the prospective portion. With regard to kidney transplant recipients, the study will include patients of both sexes, aged 18 years or older, who have undergone a kidney transplant from the donors mentioned above.

The enrollment of kidney transplant recipients will be carried out by the designated Transplant Center during routine follow-up visits.

Description

Inclusion Criteria:

In order to ensure a consistent analysis of the collected data, only kidneys from donors in the Emilia-Romagna Region whose biopsies are analyzed at the Department of Pathology of the IRCCS - Bologna University Hospital Policlinico S. Orsola-Malpighi will be considered; therefore:

  • DCD and DBD donors of both sexes from the Emilia-Romagna Region.
  • Kidney transplant recipients of both sexes from the Emilia-Romagna Region
  • Kidney transplant recipients from the Emilia-Romagna Region who are over 18 years of age.
  • Obtaining informed consent (from the recipient)

Exclusion Criteria:

  • Kidney transplant recipients enrolled in national surplus, hyperimmune, and DECK programs

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

  • Observational Models: COHORT
  • Time Perspectives: OTHER

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary objective of the study is to determine whether there is a difference-and, if so, to what extent-in terms of TMA and ATN in pre-transplant kidney biopsies from DCD donors compared to DBD donors.
Time Frame: Pre organ implantation

TMA: presence, percentage, and severity (mild/moderate/severe) ATN: presence, percentage, and severity (mild/moderate/severe)
Pre organ implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare the prevalence of different ATN groups in DCD and DBD
Time Frame: Pre organ implantation

ATN: Presence, Percentage, and Severity (mild/moderate/severe)
Pre organ implantation
Compare the epidemiological data for transplants from DCD and DBD donors
Time Frame: 1, 3, and 5 years after transplantation

Graft survival (percentage) Cause of graft loss (rejection, disease recurrence, thrombosis, other) Recipient survival (percentage) Cause of patient death (infectiou, cardiovascular, neoplastic, other) (percentage) Post-transplant complications (rejection, infectious complications, surgical complications) (percentage) PNF and DGF (percentage) Post-transplant renal function trends (eGFR calculated using the CKD-EPI formula)
1, 3, and 5 years after transplantation
Analysis of histological data from pre-implantation kidney biopsies
Time Frame: Pre organ implantation

Total Karpinski score and the individual parameters that comprise it (glomerulosclerosis, tubular atrophy, interstitial fibrosis, and thickening of the arterial wall) TMA: presence, percentage, and severity (mild/moderate/severe)
Pre organ implantation
Determine whether the relationship between TMA and clinical transplant outcomes is affected by DCD/DBD status
Time Frame: For the first 2 outcomes: January 2027 for the retrospective portion. Twice a year from 2030 until the end of the study (January 2034) for the prospective portion. For the second 2 outcomes: 1, 3, and 5 years after transplantation

DGF (percentage) PNF (percentage) Recipient survival (percent) eGFR calculated using the CKD-EPI formula (mL/min/1.73 m²)
For the first 2 outcomes: January 2027 for the retrospective portion. Twice a year from 2030 until the end of the study (January 2034) for the prospective portion. For the second 2 outcomes: 1, 3, and 5 years after transplantation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2034

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KT-BX-RER Study

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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