Prospera Enhancement by Detecting dd-cfDNA Levels
O
Oluwafisayo Adebiyi, MD
Primary Investigator
Not Recruiting
18 years - 100 years
All
Phase
N/A
500 participants needed
1 Location
Brief description of study
The current standard of care for detection of rejection in renal allograft recipients is serum creatinine, often used in combination with other blood tests such as proteinuria. Natera has developed an assay called ProsperaTM to detect the amount of donor-derived cell-free DNA (dd-cfDNA), which is a marker of kidney rejection. The purpose of this study to collect blood samples and data to assess the diagnostic capability of an updated version of the ProsperaTM test.
Detailed description of study
The purpose of this multi-center study is to evaluate the diagnostic capability of an updated version (Version 2, or V2) of ProsperaTM. Blood samples for ProsperaTM will be collected before a standard kidney biopsy scheduled due to clinical indication of AR, follow-up of a previously diagnosed AR, or as part of routine surveillance of the renal allograft. Clinical, laboratory, and biopsy data will be collected as described in this protocol. Patients enrolled in this study will be followed for up to one year from the time of enrollment.
The blood samples will be processed and analyzed at Natera. Results of the investigational test will not be used in patient management decision-making. Results will not be made available to patients or attending physicians.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: dd-cfDNA
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- 1) 18 years of age or older
- 2) At least one renal allograft transplant
- 3) Scheduled to undergo a kidney biopsy
- 4) Able to read, understand, and provide written informed consent
- 5) Willing and able to comply with the study-related procedures
Exclusion Criteria:
- 1) History of another organ transplant (i.e., aside from renal allograft)
- 2) Subject received cohort organ from an identical twin.
- 3) Currently receiving dialysis
Updated on
01 Aug 2024.
Study ID: 11786, NEPH-NATERA-PEDAL
