Donor Derived Cell-free DNA and Rejection of Kidney Allografts

Kidney Rejection Transplant Clinical Trial

Official title:

Donor Derived Cell-free DNA and Rejection of Kidney Allografts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05995379
• Other study ID #: ddcfDNA_study001
• Status: Completed
• Start date: September 21, 2011
• Est. completion date: August 9, 2022

Study information

• Verified date: August 2023
• Source: Paris Translational Research Center for Organ Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the association of dd-cfDNA with the presence, activity and severity of allograft rejection, and determine whether dd-cfDNA adds value to standard of care monitoring parameters in detecting kidney allograft rejection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: August 9, 2022
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Recipients transplanted from a deceased or living donor, who undergone a kidney allograft biopsy with clinical, biological, histological and immunological data.

• Written informed consent at the time of transplantation for the center database

Exclusion Criteria:

• Combined organ transplantation

• Pregnant women

• Bone marrow transplant

Related Conditions & MeSH terms

• Kidney Rejection Transplant

Intervention

Diagnostic Test:
• Donor-derived cell-free DNA
Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection. One additional blood sample will be collected and dd-cfDNA levels will be centrally analyzed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Paris Translational Research Center for Organ Transplantation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement	Biopsy-proven rejection refers to the confirmation of rejection through the examination of kidney allograft tissue obtained from a biopsy procedure. This includes different types of rejection, which are antibody-mediated rejection, T-cell-mediated rejection, and mixed rejection. All the allograft biopsies will be classified according to the most recognized classification (Banff 2019 classification), which provides standardized criteria for the diagnosis and the characterization of the different types of rejection.; To evaluate the association between dd-cfDNA and the occurrence of rejection, measurement of dd-cfDNA will be done at the time of each biopsy.	The allograft biopsies will be performed at 3 months and 1 year after transplant and/or in for cause biopsies performed at any time post transplantation in unstable patients.