Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Kidney transplant recipient from any donor.

Acquisition of Informed Consent to study participation and data processing.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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