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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Kidney Transplant

Study type: Observational

Funder types: Other

Identifiers

NCT06794970

CARO Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)