Transplant;Failure,Kidney Clinical Trial
— QIDNEYOfficial 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
Verified date | September 2020 |
Source | Qure Healthcare, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 175 |
Est. completion date | January 7, 2019 |
Est. primary completion date | January 7, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - A minimum of 2 years post-residency but no more than 40 years in practice - Board-certified in internal medicine - Completion of a nephrology fellowship - In a private solo or multi-group practice - Minimum threshold of 5 post-kidney transplant (KT) patients currently seen monthly - Informed, signed and voluntarily consented to be in the study Exclusion Criteria: - Not board certified in internal medicine - Have practiced as a board-certified physician for less than 2 or greater than 40 years - See <5 post-transplant patients monthly - Non-English speaking - Unable to access the internet |
Country | Name | City | State |
---|---|---|---|
United States | QURE Healthcare | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Qure Healthcare, LLC | Natera, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis-Treatment | Difference-in-differences regression analysis between the control and the intervention group's identification and treatment of hyperglycemia, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each domain. | 3 months | |
Secondary | Quality of Care: CPV scores | Difference-in-differences regression analysis between the control and the intervention group's overall quality of care scores. In each CPV case, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each case. | 3 months | |
Secondary | Workup Costs | Difference-in-differences regression analysis between between the control and the intervention group in the average cost of diagnostic tests ordered. | 3 months |
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