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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06794970

Enrollment

Registered

2025-01-27

Start date

2023-05-01

Completion date

2028-11-01

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactGaetano La Manna, MD

gaetano.lamanna@unibo.it00390512144577

Backup ContactGiorgia Comai, MD

giorgia.coma@aosp.bo.it00390512144840

Outcome results