Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476717
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
Donor-derived Cell-free DNA in Kidney Transplant Recipients
Sponsor:
Institute for Clinical and Experimental Medicine
Organization:
Institute for Clinical and Experimental Medicine
Study Overview
Official Title:
Donor-derived Cell-free DNA Dd-cfDNA Monitoring to Detect Kidney Allograft Injury and Monitor the Effect Anti-rejection Treatment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEFILE
Brief Summary:
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 ie rejection and non-rejection injuries within 12 months and to monitor the effect of anti rejection treatment
Detailed Description:
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 histologymolecular 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None