Status:
COMPLETED
Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Kidney Transplant Rejection
Antibody-mediated Rejection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04897438
Start Date
June 1 2021
End Date
September 9 2024
Last Update
January 22 2025
Active Locations (1)
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1
Charité-Universitätsmedizin
Berlin, Germany, 10117