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Post-transplant Thrombotic Microangiopathy: Evaluation of Outcomes at the Bologna Kidney Transplant Centre

Post-transplant Thrombotic Microangiopathy: Evaluation of Outcomes at the Bologna Kidney Transplant Centre

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06759961
Acronym
PT-TMA2022
Enrollment
250
Registered
2025-01-06
Start date
2023-02-01
Completion date
2033-02-01
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

Kidney Transplant, Microangiopathy

Brief summary

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

Detailed description

The primary objective is to calculate the incidence of PT-TMA in a large cohort of kidney transplant patients and to assess the association between PT-TMA and renal transplant outcome. It provides for the systematic collection of clinical information of patients with a diagnosis of PT-TMA, starting from 01/06/2016 until the approval of the study by the Ethics Committee and the issuance of the authorisation by the Director General of the IRCCS; the evaluation of the prospective data will be carried out starting from the approval of the study by the Ethics Committee and the issuance of the authorisation by the Director General of the IRCCS and will continue for 10 years. Patients enrolled prospectively will be treated according to clinical practice, in accordance with the judgement of the Physician

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Incidence of PT-TMA and renal graft outcome15 days, 1 month, 6 months after transplantation and then every 6 months thereafter* 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.

Countries

Italy

Contacts

Primary ContactMARCELLO DEMETRI, BIOLOGY
marcello.demetri2@unibo.it00393349549878
Backup ContactGiorgia Comai, MD
giorgia.comai@aosp.bo.it00390512144840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026