A Study to Assess the Updated Prospera™ Diagnostic Test
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 20-010142
About this study
The purpose of this study to collect blood samples and data to assess the diagnostic capability of an updated version of the Prospera™ test. 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 Prospera™ to detect the amount of donor-derived cell-free DNA (dd-cfDNA), which is a marker of kidney rejection.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 18 years of age or older.
- At least one renal allograft transplant.
- Scheduled to undergo a kidney biopsy.
- Able to read, understand, and provide written informed consent.
- Willing and able to comply with the study-related procedures.
Exclusion Criteria:
- History of another organ transplant (i.e., aside from renal allograft).
- Subject received cohort organ from an identical twin.
- Currently receiving dialysis.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Hasan Khamash, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available