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

The study is tissue-based, retrospective and prospective, single-centre, non-sponsored.

Primary objective: To examine patient and organ survival and eGFR variation in kidney transplant patients diagnosed histologically with cAMR.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant

Detailed Description

At the kidney transplant follow-up clinic of the UO Nephrology, Dialysis and Transplantation Unit of the IRCCS AOUBO Policlinico di Sant'Orsola, directed by Prof. G. La Manna, all patients with a diagnosis of cAMR made since 01/01/2018 and patients with a new diagnosis of cAMR made after the approval of this protocol by the Ethics Committee will be enrolled.

The study will last 5 years and 6 months.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Gaetano La Manna, MD; Phone Number: 00390512144577; Email: gaetano.lamanna@unibo.it
• Study Contact Backup: Name: Giorgia Comai, MD; Phone Number: 00390512144840; Email: giorgia.coma@aosp.bo.it

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit
      • Contact: Marcello Demetri, Biology; Phone Number: 00393349549878; Email: marcello.demetri2@unibo.it
      • Principal Investigator: Gaetano La Manna, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Based on the number of patients attending the Kidney Transplant Follow-up Outpatient Clinic of the Unit of Nephrology, Dialysis and Transplantation Prof. La Manna of the Policlinico di S. Orsola, about 50 patients will be enrolled, of whom about 25 have already been diagnosed and are undergoing treatment and about 25 new diagnoses are expected during the enrolment period in the prospective-only component.

Description

Inclusion Criteria:

• Age ≥18 years
• Kidney transplant recipients
• eGFR>15 ml/min/1.73 sq m at the time of diagnosis of cAMR
• cAMR diagnosis defined on the basis of the 2018 Banff Classification (17), made after 1/1/2018.
• Obtaining Informed Consent to Participation.

Exclusion Criteria:

• Combined transplant patients (heart-kidney, liver-kidney or kidney-pancreas)
• Histological evidence of concomitant disease (e.g. recurrence of original nephropathy or diagnosis of 'de novo' nephropathy, acute cellular rejection, polyomavirus BK nephropathy, other)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney survival post tranplant	Patient and organ survival status	1 year, 2 years
Change in eGFR	The change in eGFR will be assessed by the linear slope of eGFR (least square method) in patients who have at least 3 serum creatinine assessments. In addition to the mean annual change in eGFR from the baseline visit, it will be assessed how many patients achieved a reduction in eGFR of 40% and 50% (percentage change) between the baseline visit and the 1- and 2-year follow-up visits.	1 year, 2 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Gaetano La Manna, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CARO Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No