Kidney TransplantNCT06794970
Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation
An observational study of Kidney Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The study is tissue-based, retrospective and prospective, single-centre, non-sponsored. Primary objective: To examine patient and organ survival and eGFR variation in kidney transplant patients diagnosed histologically with cAMR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 1 Nov 2028
- 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: Based on the number of patients attending the Kidney Transplant Follow-up Outpatient Clinic of the Unit of Nephrology, Dialysis and Transplantation Prof. La Manna of the Policlinico di S. Orsola, about 50 patients will be enrolled, of whom about 25 have already been diagnosed and are undergoing treatment and about 25 new diagnoses are expected during the enrolment period in the prospective-only component.
Who may be able to join
- Age ≥18 years
- Kidney transplant recipients
- eGFR>15 ml/min/1.73 sq m at the time of diagnosis of cAMR
- cAMR diagnosis defined on the basis of the 2018 Banff Classification (17), made after 1/1/2018.
- Obtaining Informed Consent to Participation.
Who cannot join
- Combined transplant patients (heart-kidney, liver-kidney or kidney-pancreas)
- Histological evidence of concomitant disease (e.g. recurrence of original nephropathy or diagnosis of 'de novo' nephropathy, acute cellular rejection, polyomavirus BK nephropathy, other)
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
Gaetano La Manna, MD
About this study
The study is tissue-based, retrospective and prospective, single-centre, non-sponsored.
Primary objective: To examine patient and organ survival and eGFR variation in kidney transplant patients diagnosed histologically with cAMR.
Read the detailed description
At the kidney transplant follow-up clinic of the UO Nephrology, Dialysis and Transplantation Unit of the IRCCS AOUBO Policlinico di Sant'Orsola, directed by Prof. G. La Manna, all patients with a diagnosis of cAMR made since 01/01/2018 and patients with a new diagnosis of cAMR made after the approval of this protocol by the Ethics Committee will be enrolled.
The study will last 5 years and 6 months.
- Conditions
- Kidney Transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney survival post tranplant
Patient and organ survival status
Measured: 1 year, 2 years
Change in eGFR
The change in eGFR will be assessed by the linear slope of eGFR (least square method) in patients who have at least 3 serum creatinine assessments. In addition to the mean annual change in eGFR from the baseline visit, it will be assessed how many patients achieved a reduction in eGFR of 40% and 50% (percentage change) between the baseline visit and the 1- and 2-year follow-up visits.
Measured: 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 May 2023
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetano La Manna, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794970
- Sponsor's protocol ID
- CARO Study
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 27 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 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06794970
- Acronym / sponsor ID
- CARO Study
- Conditions
- Kidney Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 27 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.
The study is tissue-based, retrospective and prospective, single-centre, non-sponsored.
Primary objective: To examine patient and organ survival and eGFR variation in kidney transplant patients diagnosed histologically with cAMR.
Detailed description
At the kidney transplant follow-up clinic of the UO Nephrology, Dialysis and Transplantation Unit of the IRCCS AOUBO Policlinico di Sant'Orsola, directed by Prof. G. La Manna, all patients with a diagnosis of cAMR made since 01/01/2018 and patients with a new diagnosis of cAMR made after the approval of this protocol by the Ethics Committee will be enrolled.
The study will last 5 years and 6 months.
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
- Based on the number of patients attending the Kidney Transplant Follow-up Outpatient Clinic of the Unit of Nephrology, Dialysis and Transplantation Prof. La Manna of the Policlinico di S. Orsola, about 50 patients will be enrolled, of whom about 25 have already been diagnosed and are undergoing treatment and about 25 new diagnoses are expected during the enrolment period in the prospective-only component.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Kidney transplant recipients
- eGFR>15 ml/min/1.73 sq m at the time of diagnosis of cAMR
- cAMR diagnosis defined on the basis of the 2018 Banff Classification (17), made after 1/1/2018.
- Obtaining Informed Consent to Participation.
Key exclusion criteria (2 listed)
- Combined transplant patients (heart-kidney, liver-kidney or kidney-pancreas)
- Histological evidence of concomitant disease (e.g. recurrence of original nephropathy or diagnosis of 'de novo' nephropathy, acute cellular rejection, polyomavirus BK nephropathy, other)
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
Kidney survival post tranplant
Time frame: 1 year, 2 years
Patient and organ survival status
Change in eGFR
Time frame: 1 year, 2 years
The change in eGFR will be assessed by the linear slope of eGFR (least square method) in patients who have at least 3 serum creatinine assessments. In addition to the mean annual change in eGFR from the baseline visit, it will be assessed how many patients achieved a reduction in eGFR of 40% and 50% (percentage change) between the baseline visit and the 1- and 2-year follow-up visits.
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 27 Jan 2025.
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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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.
Gaetano La Manna, 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 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 5 inclusion and 2 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 27 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 Gaetano La Manna, MD (00390512144577, gaetano.lamanna@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney survival post tranplant (time frame: 1 year, 2 years). The study lists 2 primary outcomes in all. 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 27 Jan 2025.