The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive) (ProActive)
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|ClinicalTrials.gov Identifier: NCT04091984|
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment|
|Kidney Transplant Rejection||Diagnostic Test: Prospera|
The primary objective is to differentiate the clinical utility of Prospera testing from the use of creatinine testing as measured by the proportion of positive biopsies in post renal allograft patients.
Secondary objectives include:
- To observe the performance of the Prospera assay in detecting AR (repeated validation)
- To evaluate whether Prospera can detect AR earlier and more often than SCr
- To determine whether use of Prospera will significant decrease the overall number of surveillance biopsies when compared to routine SCr surveillance
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)|
|Actual Study Start Date :||November 6, 2019|
|Estimated Primary Completion Date :||October 1, 2026|
|Estimated Study Completion Date :||October 1, 2027|
There is no intervention in this study. Adult patients who have received a kidney allograft from a genetically different donor within 60 days and who have been selected by their healthcare provider to receive Prospera dd-cfDNA testing according to their regular interval testing schedule as part of their clinical care will have medical records pertaining to their kidney rejection status collected at each study visit.
Diagnostic Test: Prospera
No Interventions, this is an observational study.
The control arm will consist of retrospective data review of cases where a renal allograft from a genetically different donor was performed. Data pertaining to to their kidney rejection status from a minimum of 3 time points per year post allograft (up to 5 years) or until renal allograft failure will be collected.
- Efficiency of biopsies [ Time Frame: 3 years ]The proportion of clinically indicated biopsies that show Active Rejection (AR) will be measured in the Prospera arm and the control arm. Specifically, the proportion of clinically indicated biopsies showing AR in individuals with a positive donor derived-cell free DNA dd-cfDNA test at the time of Bx in the test arm, where Prospera has been integrated into the care paradigm, will be compared against the proportion of clinically indicated biopsies showing AR in the control arm.
- Graft function [ Time Frame: 3 years ]Graft function in the Prospera arm and control arm will be measured. This will be assessed by examining the average eGFR score (as calculated using serum creatinine Chronic Kidney Disease-EPIdemiology collaboration CKD_EPI equation) at year three in the Prospera arm compared to the average eGFR score determined at year three in the historical control arm.
- Evaluate the performance of Prospera [ Time Frame: 5 years ]The performance of Prospera to detect AR will be evaluated. The sensitivity, specificity, Positive & Negative Predictive Value of the assay in sub-cohorts of patients will be calculated and compared to the performance of serum creatinine to detect AR in those cohorts.
- Evaluate whether Prospera can detect acute rejection earlier than serum creatinine [ Time Frame: 3 years ]The grade of rejection observed in biopsies in the Prospera arm will be compared to the historical control arm which used serum creatinine.
- Determine if and how Prospera testing impacts patient care [ Time Frame: 5 years ]The proportion of Prospera assay results that doctors felt influenced their decisions around management of patients and biopsies will be calculated. This will be analyzed separately for the for-cause and protocol biopsies.
Biospecimen Retention: Samples With DNA
There are two arms to this study: A prospective arm and a historical control (retrospective arm).
Each participant in the Prospective arm will have received the commercially available Prospera test.
Subjects prospectively enrolled and whom consent to "Optional future Research" may have bio-specimens stored for future research.
The historical arm (retrospective cohort) will not have any bio-specimens collected or stored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091984
|Contact: Melissa Egbertemail@example.com|
|Principal Investigator:||Jonathan Bromberg, MD||University of Maryland, College Park|