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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04897438
Other study ID # CHA-NTX-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date September 1, 2024

Study information

Verified date September 2023
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
Germany Charité-Universitätsmedizin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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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