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

NCT06794970 | Recruiting

• 1 other identifier: CARO Study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (2)

• Kidney survival post tranplant

  Patient and organ survival status

  1 year, 2 years

• Change in eGFR

  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.

  1 year, 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the number of patients attending the Kidney Transplant Follow-up Outpatient Clinic of the Unit of Nephrology, Dialysis and Transplantation Prof. La Manna of the Policlinico di S. Orsola, about 50 patients will be enrolled, of whom about 25 have already been diagnosed and are undergoing treatment and about 25 new diagnoses are expected during the enrolment period in the prospective-only component.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

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

Bologna, BO, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and Urine samples

Study Officials

• Gaetano La Manna, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano La Manna, MD

CONTACT

00390512144577; gaetano.lamanna@unibo.it

Giorgia Comai, MD

CONTACT

00390512144840; giorgia.coma@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 27, 2025
• Study Start: May 1, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 27, 2025

Record last verified: 2024-12

Locations

IT (1)