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Completed

NCT Number: NCT06425497

DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY

To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels.

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Key information

Conditions

Kidney Transplant; Complications Immunosuppression

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The dosage of dnDSA

Other

Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI> 1000)

Primary outcomes

  1. Development of dnDSA in kidney transplant patients

    Time frame: • 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 outcomes

  1. Graft survival

    Time frame: 5 and 10 years

    Graft survival At 5 and 10 years

  2. Patient survival

    Time frame: 5 and 10 years

    Patient survival at 5 and 10 years

  3. Blood dosage levels of post-transplant immunosuppressive drugs

    Time frame: • 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);

  4. Donor-recipient HLA mismatch

    Time frame: Pre-transplant

    Donor-recipient HLA mismatch

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Acronym: PTV-DSAaKT

Important dates

Study start
2010
Primary completion
2023
Study completion
2024
First posted
May 22, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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