Immunosuppression, Kidney Transplant; Complications
Conditions
Brief summary
To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels.
Detailed description
Retrospective observational monocentric study at the U.O.C. of Hepatobiliary Surgery and Transplants of Tor Vergata Polyclinic. All kidney transplant patients in the indicated study period will be enrolled and followed at the U.O.C. clinic. For each patient, demographic, transplant and post-transplant data will be collected. In the latter, data relating to dnDSA will be registered, searching for a possible triggering cause at the anamnestic level. The dosage of dnDSA is performed in common clinical practice in a routine manner in all patients undergoing kidney transplant, using the method Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI\> 1000). The blood dosage of the immunosuppressor is measured during routine checks and a comparison is made between Tacrolimus-based immunosuppressive therapy and other immunosuppressive therapy, highlighting the differences in the risk of developing dnDSA and in graft and patient survival.
Interventions
OTHERThe dosage of dnDSA
Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI\> 1000)
Sponsors
University of Rome Tor Vergata
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients,both male and female over the age of 18 * Patients with at least one year of follow-up
Exclusion criteria
* Combined liver-kidney or pancreas-kidney transplants * Re-transplants * Patients with follow-up less than one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of dnDSA in kidney transplant patients | • Pre-transplant • Baseline (I PODs) • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old | Define the incidence of development of dnDSA in patients undergoing kidney transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft survival | 5 and 10 years | Graft survival At 5 and 10 years |
| Patient survival | 5 and 10 years | Patient survival at 5 and 10 years |
| Blood dosage levels of post-transplant immunosuppressive drugs | • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old | Blood dosage levels of post-transplant immunosuppressive drugs (tacrolemia, ciclosporinemia, everolemia, sirolemia); |
| Donor-recipient HLA mismatch | Pre-transplant | Donor-recipient HLA mismatch |
Outcome results
None listed