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Recruiting

NCT Number: NCT06759831

Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation

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.

Recruiting

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Key information

Conditions

Transplant Recipient (Kidney)

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

Giorgia Comai, MD

PRINCIPAL_INVESTIGATOR

Marcello Demetri, Biology

CONTACT

[email protected]

00393349549878

About this study

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.

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. the functionality of kidney transplantation

    Time frame: 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.

Study contacts

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

Gaetano La Manna, MD

CONTACT

[email protected]

+390512144577

Giorgia Comai, MD

CONTACT

[email protected]

+390512144840

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: TxBo2022

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Jan 6, 2025
Registry last updated
Jan 6, 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.

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