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

Recruiting

• Conditions: Kidney Transplant

• Registration Number: NCT06794970
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

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 Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2028-11-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kidney survival post tranplant	1 year, 2 years	Patient and organ survival status
Change in eGFR	1 year, 2 years	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.

Trial Locations

Locations (1)

IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit; 🇮🇹 Bologna, BO, Italy