Study on chronic active humoral rejection in kidney transplant patients
Official title: Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06794970 · Data updated 2026-11-12
This study looks at how chronic active humoral rejection affects kidney transplant patients' survival and kidney function over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Status | Recruiting |
| Started | May 1, 2023 |
| Main results expected | November 1, 2028 |
| Study ends | November 1, 2028 |
| Registry record updated | January 27, 2025 |
| Trial ID | NCT06794970 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adult kidney transplant recipients aged 18 years and older who have been diagnosed with cAMR and have an eGFR greater than 15 ml/min/1.73 sq m.
✕Probably not a fit
Patients who have undergone combined organ transplants or have histological evidence of other concurrent diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate patient and organ survival rates, as well as variations in estimated glomerular filtration rate (eGFR), in kidney transplant recipients diagnosed with chronic active humoral rejection (cAMR). The study will enroll patients diagnosed with cAMR at the IRCCS Sant'Orsola University Hospital since January 1, 2018, and will continue for a duration of 5 years and 6 months. It will include both retrospective and prospective data collection to provide a comprehensive understanding of the condition's impact on transplant outcomes.
Why it matters
Potential benefit: If successful, this study could improve management strategies for kidney transplant patients suffering from cAMR, potentially enhancing their long-term survival and kidney function.
How similar studies have gone: While there may be studies on kidney transplant rejection, this specific focus on chronic active humoral rejection is less common, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
Where it's running
-
IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit
Bologna, Bo, Italy Recruiting
Study contacts
- Principal investigator: Gaetano La Manna, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Gaetano La Manna, MD
- Email: gaetano.lamanna@unibo.it
- Phone: 00390512144577
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.