Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06759831

Acronym

TxBo2022

Enrollment

1293

Registered

2025-01-06

Start date

2024-11-01

Completion date

2033-10-01

Last updated

2025-01-06

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

Conditions

Transplant Recipient (Kidney)

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.

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 recipient from any donor. * Acquisition of Informed Consent to study participation and data processing.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactGiorgia Comai, MD

giorgia.comai@aosp.bo.it+390512144840

Backup ContactGaetano La Manna, MD

gaetano.lamanna@unibo.it+390512144577

Outcome results