Transplant;Failure,Kidney Clinical Trial
Official title:
Prospective, Randomized Controlled Trial Using CPV Vignettes to Assess the Clinical Utility of Natera Dd-cfDNA Test to Detect Allograft in Post-Transplant Patients
Detecting allograft injury and rejection is critical to preventing graft loss. The current
standard of care (SoC) relies on serum creatinine (SC) and biopsy to monitor for and identify
kidney injury earlier. SC has poor specificity and sensitivity and response to rejection is
often delayed. Protocol biopsy is more accurate but involves the risk of complications. A
more definitive, less invasive method for monitoring injury and early rejection is needed.
We report on the clinical utility of donor-derived cell-free DNA (dd-cfDNA) in transplant
recipients' blood, measured using a novel SNP-based mmPCR NGS methodology, to diagnose
allograft injury/rejection. In this study, investigators will measure how use of dd-cfDNA
changes clinical practice.
Five-year kidney allograft survival rates are estimated to be as low as 71.6%. A leading
cause for the high prevalence of graft loss is the delay in detecting allograft injury from
active rejection, when early diagnosis and intervention presents the greatest chance of
preserving kidney function. Despite the frequent testing called for by care protocols, low
levels of injury can go undetected due to the low specificity and sensitivity of current,
standard testing methods: checking creatinine and immunosuppressive drug levels. More
definitive graft biopsies are an option, but they are invasive, expensive and can even put
the patient at risk for graft loss and other complications, making it undesirable as a
frequent monitoring test.
Donor-derived cell-free DNA (dd-cfDNA) detected in the blood of transplant recipients has
been shown to be a non-invasive diagnostic marker for allograft injury/rejection. Natera,
Inc. has recently developed a novel single nucleotide polymorphism (SNP)-based mmPCR NGS
methodology to measure dd-cfDNA in kidney transplant recipients for the detection of
allograft injury and rejection. As a growing leader in the diagnostic space, Natera has
commissioned a randomized controlled trial to determine the clinical utility of its dd-cfDNA
detection methodology for practicing nephrologists treating kidney allograft patients. This
study is expected to fill a gap in the evidence base on the clinical utility of dd-cfDNA
testing for allograft rejection.
The study is a pre-post, two round controlled trial of care practices in a nationally
representative sample of practicing nephrologists randomly assigned to a control or an
intervention arm. All participants will be asked to propose care for a total of 6 CPV
simulated patients who are adults aged 30-75; three or more months post-transplant; and
presenting with signs, symptoms and laboratory findings suggestive of allograft rejection.
Each assessment round will consist of 3 simulated patients. In between assessment rounds,
participants randomized into the intervention arm will receive educational materials on the
new allograft rejection test.
Investigators will assess whether practicing nephrologists more effectively identify and
manage patients with possible kidney allograft rejection when given access to Natera's novel
SNP-based mmPCR-NGS test that measures dd-cfDNA, and, whether those behavioral changes
improves patient management and optimizes resource utilization.
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