SRDK0921_ Analytical Performance Study (NCT05747274) | Clinical Trial Compass
CompletedNot Applicable
SRDK0921_ Analytical Performance Study
France439 participantsStarted 2023-09-21
Plain-language summary
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects that underwent kidney transplant between January 2008 and January 2016 in the following sites: University hospital center of Nantes, AP-HP Paris-Necker, and HCL Lyon.
* Subjects transplanted from living or deceased donors.
* Patients with an available paired frozen mRNA and biopsy collected at one-year post- transplantation and archived in the DIVAT bio-collection.
* Subjects with good kidney function at one-year post-transplantation (creatininemia below 160 µmol. L-1)
* Subjects under standard immunosuppressive treatments.
Exclusion Criteria:
* Subjects that underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
* Subjects that have stopped immunosuppressive treatments.
What they're measuring
1
AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve)