NCT06801262 TreaT-Assay: the New Frontier for the Diagnosis of Acute Rejection in Kidney Transplantation
| NCT ID | NCT06801262 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Kidney Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-11-10 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-11-10 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Kidney transplantation is the standard therapy for end-stage renal disease. Acute rejection (AR) or chronic rejection along with reactive donor immunity, which counteracts organ acceptance, are among the greatest medical challenges in transplantation. In the posttransplantation setting, immunosuppressive drugs are administered to control or prevent immune reactions; however, the therapies have serious side effects. Retrospective studies have shown heterogeneous risk profiles with respect to post-transplant complications, such as AR or infection, suggesting the introduction of an individualized immunosuppressive regimen2,3,4. Biomarkers are needed for such individual therapies to discriminate between patients with different risk profiles.
Eligibility 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.
Contact & Investigator
Gaetano La Manna, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienza Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06801262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06801262 currently recruiting?
Yes, NCT06801262 is actively recruiting participants. Contact the research team at gaetano.lamanna@unibo.it for enrollment information.
Where is the NCT06801262 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06801262 clinical trial?
NCT06801262 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Gaetano La Manna, MD at IRCCS Azienza Ospedaliero-Universitaria di Bologna. The trial plans to enroll 150 participants.
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