Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients

NCT03765203 | Completed DMC

• 1 other identifier: Pro00030299
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transplant;Failure,Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of Care: CPV scores

  3 months

• Workup Costs

  3 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to Natera's dd-cfDNA test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.

Other: Clinical Performance and Value Vignettes

Intervention

EXPERIMENTAL

Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to Natera's dd-cfDNA test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.

Diagnostic Test: Natera KidneyScan; Other: Clinical Performance and Value Vignettes

Interventions

Natera KidneyScan DIAGNOSTIC_TEST

Online educational materials on Natera Kidneyscan (dd-cfDNA) and sample test results for simulated patients

Intervention

Clinical Performance and Value Vignettes OTHER

Online renal allograft simulated patients

Also known as: CPVs

Control; Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• Natera, Inc.: collaborator

Study Sites (1)

QURE Healthcare

San Francisco, California, 94109, United States

Location

Study Officials

• John W Peabody, MD PhD

  President

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John W Peabody, MD PhD

Model Details: 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 providers 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, physicians randomized into the intervention arm will receive educational materials on the new allograft rejection test.

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 5, 2018
• Study Start: November 5, 2018
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)