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

NCT04897438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Klemens Budde, MD · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-07-18
Completion
2024-09-09

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897438 on ClinicalTrials.gov