Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Kidney Transplant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Kidney survival post tranplant [Time frame: 1 year, 2 years]
- Change in eGFR [Time frame: 1 year, 2 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit — Bologna
Identifiers
NCT: NCT06794970 · CARO Study