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

NCT ID: NCT06794970

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2028-11-01

Brief Summary

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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

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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.

Conditions

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Kidney Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gaetano La Manna, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gaetano La Manna, MD

Role: CONTACT

00390512144577

Giorgia Comai, MD

Role: CONTACT

00390512144840

Facility Contacts

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Marcello Demetri, Biology

Role: primary

00393349549878

Other Identifiers

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CARO Study

Identifier Type: -

Identifier Source: org_study_id

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