CompletedNot Applicable

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

Germany40 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time from study inclusion to diagnosis of antibody-mediated rejection

Timeframe: 12 months after inclusion

Trial details

NCT IDNCT04897438

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-18

View on ClinicalTrials.gov More Kidney Transplant Rejection trials