Donor-derived Cell-free DNA in Kidney Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-21

Study Completion Date

2024-05-20

Brief Summary

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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.

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Detailed Description

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Kidney transplantation represents the best therapeutic option in patients with end-stage kidney disease. Among main causes of graft loss belongs kidney allograft rejection which is diagnosed based on histology/molecular assessment of biopsy sample. This is invasive procedure, but provides more precise result regarding type of rejection. Contrary, donor-derived cell-free DNA (dd-cfDNA) is a novel non-invasive biomarker of allograft rejection with excellent negative predictive power. Moreover it may be useful for predicting allograft injuries and resolution of injuries after treatment.

In the prospective cohort, 100 renal allograft patients will be enrolled and dd-cfDNA levels determined from blood collected at predefined time points (preTX, POD14, M1, 2, 3, 4, 6, 9, 12).

In the second cohort, 40 patients will be enrolled at the time of biopsy with histological and/or molecular diagnosis of rejection and dd-cfDNA levels measured just before initiation of treatment and then at week 1, 2 and 3 after biopsy.

Peripheral blood will be collected in 2x 10 ml cfDNA (Streck) collection tubes for each study visit and dd-cfDNA will be quantified by the Prospera™ test (Natera Inc., Austin, Texas).

All patients will receive standard of care treatment according to centre protocol and no patients or providers will receive the results of dd-cfDNA testing during the study. Study protocol and patient informed consent were approved by Ethical committee.

Conditions

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Kidney Transplantation Acute Rejection of Renal Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective monitoring within 1 year follow-up

Patients after kidney transplantation from deceased donors (n=100) were prospectively enrolled and dd-cf DNA levels were measured at defined timepoints (0, D14, 1,2,3,4,6,9 and 12 months) within 12 months.

Biopsy

Intervention Type PROCEDURE

Kidney allograft biopsy

Blood Biomarkers - cfDNA

Intervention Type DIAGNOSTIC_TEST

dd-cfDNA

The effect of treatment cohort

Patients were enrolled at the time of biopsy with histologic and /or molecular signs of rejection. Donor-derived cell-free DNA (dd-cf DNA) were measured at the time of biopsy before centre standard of care treatment and then at weeks 1, 2 and 3 after biopsy.

Biopsy

Intervention Type PROCEDURE

Kidney allograft biopsy

Blood Biomarkers - cfDNA

Intervention Type DIAGNOSTIC_TEST

dd-cfDNA

Antirejection therapy

Intervention Type DRUG

Patients will receive standard antirejection therapy according to center protocol.

Interventions

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Biopsy

Kidney allograft biopsy

Intervention Type PROCEDURE

Blood Biomarkers - cfDNA

dd-cfDNA

Intervention Type DIAGNOSTIC_TEST

Antirejection therapy

Patients will receive standard antirejection therapy according to center protocol.

Intervention Type DRUG

Other Intervention Names

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dd-cfDNA

Eligibility Criteria

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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