New method for diagnosing acute rejection in kidney transplants
TreaT-Assay: the New Frontier for the Diagnosis of Acute Rejection in Kidney Transplantation
This study is testing a new way to diagnose acute rejection in kidney transplants by using a special test on urine to help tailor treatments for better recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06801262 on ClinicalTrials.gov |
What this trial studies
This study focuses on improving the diagnosis of acute rejection in kidney transplantation by utilizing a novel assay called the TreaT assay. The assay monitors and characterizes reactive T cells from the transplanted kidney, using donor-derived cells obtained from the recipient's urine. By identifying specific biomarkers, the study aims to develop individualized immunosuppressive regimens that can better manage post-transplant complications while minimizing side effects. The approach is based on previous findings that highlight the correlation between donor reactive T-cells and acute rejection.
Who should consider this trial
Good fit: Ideal candidates for this study are adults undergoing living or cadaveric kidney transplantation.
Not a fit: Patients under the age of 18 or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to more personalized and effective immunosuppressive therapies for kidney transplant patients, improving graft survival and patient outcomes.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in utilizing biomarkers for transplant rejection diagnosis, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria for subjects in group A Healthy adult subjects who will be selected from blood donors belonging to the Metropolitan Immunohematology and Transfusion Medicine Service. It should be noted that for subjects belonging to group A, informed consent is not required as the samples are provided in anonymous manner and completely unrelated to the patient. * Inclusion criteria for study patients group B 1. Subjects undergoing living or cadaveric kidney transplantation afferent to the O.U. of Nephrology, Dialysis and Renal Transplantation, St. Orsola Hospital, Pavilion 15. 2. Patients who intend to participate in the study. Exclusion Criteria: * Exclusion criteria for subjects in group A None * Exclusion criteria for patients in study group B 1. Subjects under the age of 18 years. 2. Patients who are unable to make explicit their informed consent.
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Gaetano La Manna, MD — IRCCS Azienza Ospedaliero-Universitaria di Bologna
- Study coordinator: Gaetano La Manna, MD
- Email: gaetano.lamanna@unibo.it
- Phone: +390512144577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.