Actively Recruiting

Age: 18Years +
All Genders
ID06794970

Tissue Study on Chronic Active Humoral Rejection in Kidney Transplant Patients Observational Study on Kidney Survival and Function Changes

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-27

50

Participants Needed

1

Research Sites

287 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying kidney transplant patients diagnosed with chronic active humoral rejection (cAMR) to understand patient and organ survival as well as changes in kidney function over time. This tissue-based study includes both retrospective and prospective analysis and is conducted at a single center. The main goal is to assess how patients and their kidney grafts fare, focusing on kidney function measured by estimated glomerular filtration rate (eGFR) at one and two years after diagnosis. Participants are patients who have received a kidney transplant and have been diagnosed with cAMR since January 1, 2018, or are newly diagnosed after the study protocol approval. The diagnosis of cAMR is based on the 2018 Banff Classification. The study will follow these patients for a total of five years and six months to monitor outcomes. No specific interventions are detailed, as this is an observational tissue study. During the study, patients will be monitored at the kidney transplant follow-up clinic where their kidney function and survival will be tracked. Researchers will evaluate kidney survival and changes in eGFR at one and two years post-diagnosis. Data will be collected to better understand the progression and impact of cAMR in kidney transplant recipients. Participants will provide informed consent to join the study.

CONDITIONS

Official Title

Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Kidney transplant recipients
  • eGFR greater than 15 ml/min/1.73 m² at time of cAMR diagnosis
  • Diagnosis of chronic active humoral rejection (cAMR) based on 2018 Banff Classification, made after January 1, 2018
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Patients who have received combined transplants (heart-kidney, liver-kidney, or kidney-pancreas)
  • Evidence of other kidney diseases including recurrence of original nephropathy, new nephropathy, acute cellular rejection, polyomavirus BK nephropathy, or other histological diseases

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit

Bologna, BO, Italy, 40138

Actively Recruiting

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Research Team

G

Gaetano La Manna, MD

G

Giorgia Comai, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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