New method for diagnosing acute rejection in kidney transplants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.