NCT04897438

Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection

Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection in Kidney Transplant Recipient with Donor-specific Antibodies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Kidney Transplant Rejection
• Antibody-mediated Rejection
• Kidney Transplant Failure

Interventions

Type	Name	Description
PROCEDURE	Kidney allograft biopsy depending on donor-derived cell-free DNA levels	Kidney allograft biopsy is performed, when absolute levels of donor-derived cell-free DNA are above 50 copies/ml

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-07-18
• Completion: 2024-09-09
• First posted: 2021-05-21
• Last updated: 2025-01-22

Locations

1 site across 1 country: Germany