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

Last updated: January 24, 2025
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06794970
CARO Study
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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), madeafter 1/1/2018.

  • Obtaining Informed Consent to Participation.

Exclusion

Exclusion Criteria:

  • Combined transplant patients (heart-kidney, liver-kidney or kidney-pancreas)

  • Histological evidence of concomitant disease (e.g. recurrence of originalnephropathy or diagnosis of 'de novo' nephropathy, acute cellular rejection,polyomavirus BK nephropathy, other)

Study Design

Total Participants: 50
Study Start date:
May 01, 2023
Estimated Completion Date:
November 01, 2028

Study 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.

Connect with a study center

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

    Bologna, BO 40138
    Italy

    Active - Recruiting

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