About this trial
It is a retrospective-prospective, single-centre, non-pharmacological, retrospective tissue study carried out for scientific and health protection purposes. It involves the systematic collection of clinical information from patients diagnosed with PT-TMA
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Living kidney transplant recipient, brain death cadaver donor, cardiac death cadaver donor, single kidney transplant, double kidney transplant, combined kidney transplant
Acquisition of Informed Consent to participate in the study and to process personal, special and genetic data
Disqualifiers
None
Trial population
In the period from 01/06/2016 until 01/09/2022 at the Transplant Centre of the Nephrology, Dialysis, Transplantation Unit of our hospital, 715 kidney transplants were performed. The incidence of post-transplant thrombotic microangiopathy varies according to literature data up to a maximum of 14-15%. The estimated population size as the object of the retrospective study is therefore approximately 750 patients in total and approximately 100 patients with PT-TMA. The size of the population as the subject of the prospective study is approximately 1200 transplanted patients with approximately 150/180 patients developing PT-TMA.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of PT-TMA and renal graft outcome
* The incidence of PT-TMA will be assessed in this cohort by considering the number of events over the total number of patients in the observation period. * The renal graft outcome will be assessed by considering graft failure events (return to ESKD, kidney retransplantation) and calculating the eGFR at 15 days, 1 month, 6 months after transplantation and then every 6 months thereafter.
Sponsors and contacts
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