Transplant;Failure,KidneyQIDNEYNCT03765203
Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients
A study testing Natera KidneyScan and Clinical Performance and Value Vignettes in people with Transplant;Failure,Kidney, run by Qure Healthcare, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Transplant;Failure,Kidney
- What is being tested?
- Natera KidneyScan and Clinical Performance and Value Vignettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to 7 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Transplant;Failure,Kidney
- Being tested
- Natera KidneyScan, Clinical Performance and Value Vignettes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natera KidneyScanDiagnostic test
Online educational materials on Natera Kidneyscan (dd-cfDNA) and sample test results for simulated patients
Clinical Performance and Value VignettesOther
Also called CPVs
Online renal allograft simulated patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Natera KidneyScan; Other: Clinical Performance and Value Vignettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
Workup Costs
Difference-in-differences regression analysis between between the control and the intervention group in the average cost of diagnostic tests ordered.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start5 Nov 2018
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant;Failure,KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Natera, Inc.
- Responsible party
- Principal investigator, David Paculdo, Qure Healthcare, LLC
- Investigators
- John W Peabody, MD PhD, Principal investigator, President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765203
- Sponsor's protocol ID
- Pro00030299
- Acronym
- QIDNEY
- Status last verified
- Sep 2020
- First submitted
- 30 Nov 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03765203
- Acronym / sponsor ID
- QIDNEY / Pro00030299
- Conditions
- Transplant;Failure,Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Natera, Inc.
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Clinical Performance and Value VignettesControl 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. |
| Intervention | Experimental | Diagnostic Test: Natera KidneyScan, Other: Clinical Performance and Value VignettesIntervention 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natera KidneyScanOnline educational materials on Natera Kidneyscan (dd-cfDNA) and sample test results for simulated patients | Diagnostic test | Intervention |
| Clinical Performance and Value VignettesAlso: CPVsOnline renal allograft simulated patients | Other | Control, Intervention |
Primary outcome
Diagnosis-Treatment
Time frame: 3 months
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.
2 secondary outcomes
Quality of Care: CPV scores
Time frame: 3 months
Workup Costs
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Peabody, MD PhD principal investigator
President
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natera KidneyScan and Clinical Performance and Value Vignettes in people with Transplant;Failure,Kidney, run by Qure Healthcare, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis-Treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.