Transplant Recipient (Kidney)TxBo2022NCT06759831
Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation
An observational study of Transplant Recipient (Kidney), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This is a retrospective, prospective, single-centre, non-pharmacological observational study. The primary objective is to investigate the long-term prognosis of the kidney transplant function of different types of donors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Recipient (Kidney)
- How many people
- 1,293 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to 1 Oct 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: The medical records of all patients undergoing kidney transplantation performed at the O.U. Nephrology, Dialysis and Transplantation of IRCCS AOUBO from January 2017 until the start of the study will be retrospectively reviewed. After that, all kidney transplant recipients over the next 9 years, performed c/o the U.O. Nephrology, Dialysis and Transplantation of IRCCS AOUBO, will be prospectively enrolled.
Who may be able to join
- Age ≥ 18 years.
- Kidney transplant recipient from any donor.
- Acquisition of Informed Consent to study participation and data processing.
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
This is a retrospective, prospective, single-centre, non-pharmacological observational study.
The primary objective is to investigate the long-term prognosis of the kidney transplant function of different types of donors.
Read the detailed description
It provides for the systematic collection of clinical information of patients undergoing kidney transplantation from 01/01/2017 until the Ethics Committee approves the study and the Director General of the IRCCS issues the authorisation. Data collection will continue for 9 years after the start of the study.
Patients participating in the prospective part will be treated according to clinical practice, in accordance with the judgement of the physician and the information reported in the Technical Data Sheet of each individual product of any concomitant therapies administered according to clinical practice. There are no additional study-specific visits/examinations for enrolled patients and any data recorded for the purposes of the study is collected for care purposes during the patient's normal course of treatment.
- Conditions
- Transplant Recipient (Kidney)
What is being measured
The primary outcome is the main question the study is designed to answer.
the functionality of kidney transplantation
the functionality of the kidney transplant will be assessed by considering the events of graft failure (return to ESRD, kidney retransplantation), and eGFR change (calculated according to the CKD-EPI formula) at 1 month, 6 months, 1 year, 5 years and 10 years after transplantation. A loss of eGFR of 40% within the first 3 years of follow-up from the baseline visit (at discharge from transplantation) is considered a valid surrogate end-point of ESRD.
Measured: 1 month, 6 months, 1 year, 5 years, 10 years
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 Nov 2024
- Primary completion1 Oct 2033 (estimated)
- Study completion1 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Recipient (Kidney)Studies 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
- 1,293 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
- NCT06759831
- Sponsor's protocol ID
- TxBo2022
- Acronym
- TxBo2022
- Status last verified
- Oct 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
- Individual data sharing
- 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
- Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation
- ClinicalTrials.gov ID
- NCT06759831
- Acronym / sponsor ID
- TxBo2022 / TxBo2022
- Conditions
- Transplant Recipient (Kidney)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,293 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Oct 2033 (estimated)
- Study completion
- 1 Oct 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.
This is a retrospective, prospective, single-centre, non-pharmacological observational study.
The primary objective is to investigate the long-term prognosis of the kidney transplant function of different types of donors.
Detailed description
It provides for the systematic collection of clinical information of patients undergoing kidney transplantation from 01/01/2017 until the Ethics Committee approves the study and the Director General of the IRCCS issues the authorisation. Data collection will continue for 9 years after the start of the study.
Patients participating in the prospective part will be treated according to clinical practice, in accordance with the judgement of the physician and the information reported in the Technical Data Sheet of each individual product of any concomitant therapies administered according to clinical practice. There are no additional study-specific visits/examinations for enrolled patients and any data recorded for the purposes of the study is collected for care purposes during the patient's normal course of treatment.
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
- The medical records of all patients undergoing kidney transplantation performed at the O.U. Nephrology, Dialysis and Transplantation of IRCCS AOUBO from January 2017 until the start of the study will be retrospectively reviewed. After that, all kidney transplant recipients over the next 9 years, performed c/o the U.O. Nephrology, Dialysis and Transplantation of IRCCS AOUBO, will be prospectively enrolled.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Kidney transplant recipient from any donor.
- Acquisition of Informed Consent to study participation and data processing.
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
the functionality of kidney transplantation
Time frame: 1 month, 6 months, 1 year, 5 years, 10 years
the functionality of the kidney transplant will be assessed by considering the events of graft failure (return to ESRD, kidney retransplantation), and eGFR change (calculated according to the CKD-EPI formula) at 1 month, 6 months, 1 year, 5 years and 10 years after transplantation. A loss of eGFR of 40% within the first 3 years of follow-up from the baseline visit (at discharge from transplantation) is considered a valid surrogate end-point of ESRD.
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.
- Individual participant dataSharing planned: No
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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 Transplant Recipient (Kidney), 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 Giorgia Comai, MD (+390512144840, giorgia.comai@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the functionality of kidney transplantation (time frame: 1 month, 6 months, 1 year, 5 years, 10 years). 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.