Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation

Recruiting

• Conditions: Transplant Recipient (Kidney)

• Registration Number: NCT06759831
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

This is a retrospective, prospective, single-centre, non-pharmacological observational study.

The primary objective is to investigate the long-term prognosis of the kidney transplant function of different types of donors.

Detailed Description

It provides for the systematic collection of clinical information of patients undergoing kidney transplantation from 01/01/2017 until the Ethics Committee approves the study and the Director General of the IRCCS issues the authorisation. Data collection will continue for 9 years after the start of the study.

Patients participating in the prospective part will be treated according to clinical practice, in accordance with the judgement of the physician and the information reported in the Technical Data Sheet of each individual product of any concomitant therapies administered according to clinical practice. There are no additional study-specific visits/examinations for enrolled patients and any data recorded for the purposes of the study is collected for care purposes during the patient's normal course of treatment.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-01
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2033-10-01
• Study Completion: 2033-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1293

Inclusion Criteria

• Age ≥ 18 years.
• Kidney transplant recipient from any donor.
• Acquisition of Informed Consent to study participation and data processing.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the functionality of kidney transplantation	1 month, 6 months, 1 year, 5 years, 10 years	the functionality of the kidney transplant will be assessed by considering the events of graft failure (return to ESRD, kidney retransplantation), and eGFR change (calculated according to the CKD-EPI formula) at 1 month, 6 months, 1 year, 5 years and 10 years after transplantation. A loss of eGFR of 40% within the first 3 years of follow-up from the baseline visit (at discharge from transplantation) is considered a valid surrogate end-point of ESRD.

Trial Locations

Locations (1)

IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit; 🇮🇹 Bologna, BO, Italy