Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06794970

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bologna, BO, 40138, Italy

Location status: Recruiting

Location contact

Gaetano La Manna, MD

PRINCIPAL_INVESTIGATOR

Marcello Demetri, Biology

CONTACT

[email protected]

00393349549878

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Kidney survival post tranplant

    Time frame: 1 year, 2 years

    Patient and organ survival status

  2. Change in eGFR

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gaetano La Manna, MD

CONTACT

[email protected]

00390512144577

Giorgia Comai, MD

CONTACT

[email protected]

00390512144840

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.