Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06425497
Other study ID # sperimentazioni PTV 92.24
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date May 6, 2024

Study information

Verified date May 2024
Source University of Rome Tor Vergata
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date May 6, 2024
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The 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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Rome Tor Vergata

Outcome

Type Measure Description Time frame Safety issue
Primary Development of dnDSA in kidney transplant patients Define the incidence of development of dnDSA in patients undergoing kidney transplantation. • 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
Secondary Graft survival Graft survival At 5 and 10 years 5 and 10 years
Secondary Patient survival Patient survival at 5 and 10 years 5 and 10 years
Secondary Blood dosage levels of post-transplant immunosuppressive drugs Blood dosage levels of post-transplant immunosuppressive drugs (tacrolemia, ciclosporinemia, everolemia, sirolemia); • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old
Secondary Donor-recipient HLA mismatch Donor-recipient HLA mismatch Pre-transplant
See also
  Status Clinical Trial Phase
Recruiting NCT05060991 - Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients Phase 4
Completed NCT02833805 - NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia Phase 2
Completed NCT01252537 - Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia N/A
Completed NCT01678937 - Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents N/A
Completed NCT00621699 - Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects Phase 1
Completed NCT00788021 - Protective Immunity Project 01 N/A
Active, not recruiting NCT00166842 - Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets Phase 4
Recruiting NCT05616130 - Pathological Myeloid Activation After Sepsis and Trauma
Completed NCT03117192 - Zinc Supplementation on Cellular Immunity in Thalassemia Major Phase 4
Recruiting NCT01568697 - Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Not yet recruiting NCT06024226 - Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC
Not yet recruiting NCT04961229 - Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response Phase 4
Completed NCT03139565 - High Dose vs. Standard Influenza Vaccine in Adult SOT Phase 3
Completed NCT02547753 - Dental Extractions Among Renal Transplant Recipients
Completed NCT01702207 - Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk Phase 4
Completed NCT00626808 - A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children Phase 4
Completed NCT00419575 - Renal Transplantation With Immune Monitoring N/A
Completed NCT00783380 - Influenza Vaccination in Immunocompromized Patients Phase 4
Completed NCT04835948 - Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
Recruiting NCT05043870 - Combined Immunosuppression for Pediatric Crohn's Disease Phase 4