Kidney Transplant Rejection Clinical Trial
— cfDNA-DSAOfficial title:
Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection in Kidney Transplant Recipient With Donor-specific Antibodies
Verified date | September 2023 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | September 1, 2024 |
Est. primary completion date | July 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité-Universitätsmedizin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time from study inclusion to diagnosis of antibody-mediated rejection | Time from study inclusion date to biopsy-proven diagnosis of active or chronic active antibody-mediated rejection | 12 months after inclusion | |
Secondary | Sensitivity of absolute dd-cfDNA for detection of ABMR | Sensitivity of dd-cfDNA > 50 copies/ml to predict the occurence of active or chronic active ABMR in patients with DSA. | 12 Months | |
Secondary | Specificity of absolute dd-cfDNA for detection of ABMR | Specificity of dd-cfDNA > 50 copies/ml to predict the occurence of active or chronic active ABMR in patients with DSA. | 12 Months | |
Secondary | Receiver operating characteristics (ROC) analysis of absolute dd-cfDNA for detection of ABMR | ROC analysis for dd-cfDNA to predict the occurence of active or chronic active ABMR in patients with DSA. | 12 Months | |
Secondary | Sensitivity of intraindividual dd-cfDNA changes for detection of ABMR | Sensitivity of dd-cfDNA increase of > 25% to predict the occurence of active or chronic active ABMR in patients with DSA. | 12 Months | |
Secondary | Sensitivity of combined dd-cfDNA criterion for detection of ABMR | Sensitivity of the combination of "dd-cfDNA increase of > 25%" OR "absolute dd-cfDNA > 50 copies/ml" to predict the occurence of active or chronic active ABMR in patients with DSA. | 12 Months | |
Secondary | Clinical Outcome - estimated glomerular filtration rate (eGFR) 12 Months | Difference between eGFR decline after 12 months between control group and intervention group. | 12 Months | |
Secondary | Clinical Outcome - eGFR 24 Months | Difference between eGFR decline after 24 months between control group and intervention group. | 24 Months | |
Secondary | Clinical Outcome - albuminuria 12 Months | Difference between albuminuria after 12 months between control group and intervention group. | 12 Months | |
Secondary | Clinical Outcome - albuminuria 24 Months | Difference between albuminuria after 24 months between control group and intervention group. | 24 Months | |
Secondary | Clinical Outcome - Death-censored Graft Failure 12 Months | Difference in Death-censored Graft Failure after 12 months between control group and intervention group. | 12 Months | |
Secondary | Clinical Outcome - Death-censored Graft Failure 24 Months | Difference in Death-censored Graft Failure after 24 months between control group and intervention group. | 24 Months | |
Secondary | Clinical Outcome - Mortality 12 Months | Difference in Mortality after 12 months between control group and intervention group. | 12 Months | |
Secondary | Clinical Outcome - Mortality 24 Months | Difference in Mortality after 24 months between control group and intervention group. | 24 Months | |
Secondary | Clinical Outcome - Severe Infection 12 Months | Difference in occurence of severe infections (hospitalization, organ failure, death) during 12 months between control group and intervention group. | 12 Months | |
Secondary | Clinical Outcome - Severe Infection 24 Months | Difference in occurence of severe infections (hospitalization, organ failure, death) during 24 months between control group and intervention group. | 24 Months | |
Secondary | Adverse Events of Kidney Transplant Biopsy | Occurence of Complications from Kidney Transplant Biopsies, including Duration and potential therapy to treat the adverse event. | 12 Months | |
Secondary | Rate of ABMR | Number of biopsy proven active or chronic active ABMR in the cohort. | 12 Months | |
Secondary | DSA Levels 0 Months | Mean fluorescence intensity of immunodominant DSA | at inclusion | |
Secondary | DSA Levels 12 Months | Mean fluorescence intensity of immunodominant DSA at 12 months | 12 months | |
Secondary | DSA Levels 24 Months | Mean fluorescence intensity of immunodominant DSA at 24 months | 24 months | |
Secondary | Immunosuppressive Regimen | Report of immunosuppressive medication at the following time points: 0,1,3,6,9,12,24 months, changes of medication, additional therapies such as plasmapheresis, or experimental therapies. | 24 months | |
Secondary | Time from first DSA occurrence to diagnosis of antibody-mediated rejection | Time from first DSA occurrence to biopsy-proven diagnosis of active or chronic active antibody-mediated rejection | 12 months after inclusion |
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