MicroangiopathyPT-TMA2022NCT06759961
Post-transplant Thrombotic Microangiopathy: Evaluation of Outcomes at the Bologna Kidney Transplant Centre
An observational study of Microangiopathy and Kidney Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microangiopathy, Kidney Transplant
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 1 Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit
Bologna, BO, 40138
Marcello Demetri, Biology, 00393349549878, marcello.demetri2@unibo.it
Giorgia Comai, MD
About this study
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
Read the 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
- Conditions
- Microangiopathy, Kidney Transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days, 1 month, 6 months after transplantation and then every 6 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Feb 2023
- Primary completion1 Feb 2033 (estimated)
- Study completion1 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroangiopathyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgia Comai, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759961
- Sponsor's protocol ID
- PT-TMA2022
- Acronym
- PT-TMA2022
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-transplant Thrombotic Microangiopathy: Evaluation of Outcomes at the Bologna Kidney Transplant Centre
- ClinicalTrials.gov ID
- NCT06759961
- Acronym / sponsor ID
- PT-TMA2022 / PT-TMA2022
- Conditions
- Microangiopathy, Kidney Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2033 (estimated)
- Study completion
- 1 Feb 2033 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giorgia Comai, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microangiopathy and Kidney Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARCELLO DEMETRI, BIOLOGY (00393349549878, marcello.demetri2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PT-TMA and renal graft outcome (time frame: 15 days, 1 month, 6 months after transplantation and then every 6 months thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.