Post-transplant Thrombotic Microangiopathy: Evaluation of Outcomes at the Bologna Kidney Transplant Centre (PT-TMA2022)

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

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant; Microangiopathy

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

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Marcello Demetri, Biology; Phone Number: 00393349549878; Email: marcello.demetri2@unibo.it
• Study Contact Backup: Name: Giorgia Comai, MD; Phone Number: 00390512144840; Email: giorgia.comai@aosp.bo.it

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit
      • Contact: Marcello Demetri, Biology; Phone Number: 00393349549878; Email: marcello.demetri2@unibo.it
      • Principal Investigator: Giorgia Comai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 days, 1 month, 6 months after transplantation and then every 6 months thereafter

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Giorgia Comai, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Cardiovascular Diseases; Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia; Vascular Diseases; Thrombotic Microangiopathies
• Other Study ID Numbers: PT-TMA2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No