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NCT Number: NCT06759961

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit

Bologna, BO, 40138, Italy

Location status: Recruiting

Location contact

Giorgia Comai, MD

PRINCIPAL_INVESTIGATOR

Marcello Demetri, Biology

CONTACT

[email protected]

00393349549878

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Incidence of PT-TMA and renal graft outcome

    Time frame: 15 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giorgia Comai, MD

CONTACT

[email protected]

00390512144840

MARCELLO DEMETRI, BIOLOGY

CONTACT

[email protected]

00393349549878

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: PT-TMA2022

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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