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Clinical trial

Donor-derived Cell-free DNA (Dd-cfDNA) Monitoring to Detect Kidney Allograft Injury and Monitor the Effect Anti-rejection Treatment

ID
Name
15689/21
Description
Donor-derived cell-free DNA (dd-cfDNA) is a promising non-invasive biomarker of kidney allograft rejection. In this prospective, single center, observational monitoring study, we aim to evaluate a role of dd-cfDNA in predicting kidney allograft injuries, i.e. rejection and non-rejection injuries within 12 months, and to monitor the effect of anti rejection treatment.
Trial arms
Trial start
2021-10-21
Estimated PCD
2024-05-12
Trial end
2024-12-12
Status
Active (not recruiting)
Treatment
Biopsy
Kidney allograft biopsy
Arms:
Prospective monitoring within 1 year follow-up, The effect of treatment cohort
Blood Biomarkers - cfDNA
dd-cfDNA
Arms:
Prospective monitoring within 1 year follow-up, The effect of treatment cohort
Other names:
dd-cfDNA
Antirejection therapy
Patients will receive standard antirejection therapy according to center protocol.
Arms:
The effect of treatment cohort
Size
143
Primary endpoint
dd-cfDNA
12 months
dd-cfDNA
4 weeks
Eligibility criteria
Inclusion Criteria: * Recipient age ≥ 18 years and \<85 years * Written Informed Consent cohort 1 * deceased donor kidney transplant recipient cohort 2 * patients with kidney allograft biopsy at center showing any type of rejection which is going to be treated * patient wishing to repeatedly travel to center Exclusion Criteria: cohort 1 * living donor * multiple transplant * dual transplant * haematopoetic stem cell transplant in a history
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'peripheral blood samples of recipient'}, 'enrollmentInfo': {'count': 143, 'type': 'ACTUAL'}}
Updated at
2024-06-27

1 organization

1 product

2 indications

Organization
Institute for Clinical and Experimental Medicine
Product
Antirejection therapy
Indication
Kidney Transplant
Indication
Acute Rejection of Renal Transplant