Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection (cfDNA-DSA)

Charité University Medicine Berlin

Status: Completed

Conditions: Antibody-mediated Rejection; Kidney Transplant Failure; Kidney Transplant Rejection

Treatments: Procedure: Kidney allograft biopsy depending on donor-derived cell-free DNA levels

Study type: Interventional

Funder types: Other

Identifiers

NCT04897438

CHA-NTX-001

Details and patient eligibility

About

Patients after kidney transplantation who develop donor-specific antibodies (DSA) are at high risk for antibody-mediated rejection (ABMR). Donor-derived cell-free DNA (dd-cfDNA) levels have been shown to be increased in patients with active or chronic active ABMR. This study aims to evaluate if repeated analysis of dd-cfDNA in patients with DSA and kidney allograft biopsy which is triggered by increased levels of dd-cfDNA can lead to early diagnosis of active or chronic active ABMR among these patients.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients 18 years or older
• patients provided written informed consent
• patients after kidney transplantation
• functioning kidney allograft, at least after 180 days after last transplantation
• estimated glomerular filtration rate above 20 ml/min/1.73m^2
• detection of DSA

Exclusion criteria

• patients younger than 18 years
• patients unable or did not provide written informed consent
• pregnant or breastfeeding persons
• patients with increased bleeding risk
• patients with multi-organ transplantation
• patients who underwent kidney allograft biopsy after first detection of DSA
• biopsy-proven antibody-mediated rejection
• participation in another interventional clinical trial

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention

Experimental group

Description:

Additionally to standard of care, measurements for donor-derived cell-free DNA (dd-cfDNA) are performed at months 0, 1, 3, 6, 9, and 12. If absolute levels of dd-cfDNA are \> 50 copies/ml, the patients receive a kidney allograft biopsy. Additionally, kidney allograft biopsies are performed according to standard of care as determined by the treating physicians.

Treatment:

Procedure: Kidney allograft biopsy depending on donor-derived cell-free DNA levels

Control

No Intervention group

Description:

Additionally to standard of care, measurements for donor-derived cell-free DNA (dd-cfDNA) are performed at months 0, 1, 3, 6, 9, and 12. These measurements are not used to guide kidney allograft biopsies. Those are performed according to standard of care as determined by the treating physicians.