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The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive) (ProActive)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091984
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by (Responsible Party):
Natera, Inc.

Brief Summary:
The ProActive registry is a longitudinal, multi-center study with a prospective arm observing clinical care for patients receiving physician ordered Prospera, an allograft rejection test, and a historical control arm collecting data on cases at the same sites whose kidney allograft rejection status was managed with Serum Creatinine SCr/estimated Glomerular Filtration Rate eGFR. This registry will compare patient management and outcomes in patients who receive Prospera (Prospera arm) to the outcomes of the historical control group (control arm) to determine Prospera's clinical utility. High-risk subjects defined as having a biopsy-demonstrated rejection event or at least one pre-existing Donor Specific Antibody DSA with total Mean Fluorescent Intensity MFI>3000 or a calculated Panel Reactive Antibodies cPRA>70% will be followed for an additional period up to 24 months in both the Prospera arm and historical control arm.

Condition or disease Intervention/treatment
Kidney Transplant Rejection Diagnostic Test: Prospera

Detailed Description:

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Case-Control
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prospera Arm
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.

Control Arm
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 3,000 adult renal allograft participants will be enrolled in this study, and data will be collected from a de-identified cohort of approximately 1,000 historical control patients who had a renal allograft.
Criteria

Inclusion Criteria Prospera Arm:

  1. 18 years of age or older
  2. Renal allograft (kidney transplant) within the 60 days of initiating Prospera testing
  3. A genetically different donor (not an identical twin)
  4. Selected by a healthcare provider to receive Prospera dd-cfDNA test according to the regular interval testing schedule as part of their practical care
  5. Able to read, understand and provide written informed consent
  6. Willing and able to comply with the study visit schedule and study requirements

Exclusion Criteria Prospera Arm:

  1. Pregnant
  2. Being tested with another dd-cfDNA test
  3. History of another organ transplant (i.e. aside from renal allograph)
  4. A serious medical condition that may adversely affect ability to participate in the study (e.g, dementia, current diagnosis of cancer)

Inclusion Criteria Control Arm:

  1. 18 years of age or older at the time of transplant
  2. Had a renal allograft
  3. Had a genetically different donor
  4. Had a minimum of three evaluations per year during the three years since the renal allograft or until allograft failure

Exclusion Criteria Control Arm:

  1. Female patients who were pregnant at any time during the 3-year historical control data collection period
  2. Had a transplanted organ other than kidney
  3. Received results from a dd-cfDNA test designed to assess renal allograft rejection during the historical control data collection period

Information from the National Library of Medicine

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


Contacts
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Contact: Melissa Egbert 650-249-9090 proactive@natera.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Natera, Inc.
University of Maryland, College Park
Investigators
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Principal Investigator: Jonathan Bromberg, MD University of Maryland, College Park
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Responsible Party: Natera, Inc.
ClinicalTrials.gov Identifier: NCT04091984    
Other Study ID Numbers: 18-039-TRP
Pro00037470 ( Other Identifier: Advarra IRB )
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Natera, Inc.:
donor-derived cfDNA