Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation

NCT06759831 | Recruiting

• 1 other identifier: TxBo2022
• Study Type: observational
• Target: 1,293
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant Recipient (Kidney)

Outcome Measures

Primary Outcomes (1)

• the functionality of kidney transplantation

  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.

  1 month, 6 months, 1 year, 5 years, 10 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

The medical records of all patients undergoing kidney transplantation performed at the O.U. Nephrology, Dialysis and Transplantation of IRCCS AOUBO from January 2017 until the start of the study will be retrospectively reviewed. After that, all kidney transplant recipients over the next 9 years, performed c/o the U.O. Nephrology, Dialysis and Transplantation of IRCCS AOUBO, will be prospectively enrolled.

You may qualify if:

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

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

Study Officials

• Giorgia Comai, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgia Comai, MD

CONTACT

+390512144840; giorgia.comai@aosp.bo.it

Gaetano La Manna, MD

CONTACT

+390512144577; gaetano.lamanna@unibo.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 6, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 1, 2033
• Study Completion (Estimated): October 1, 2033
• Last Updated: January 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)