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Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients. (SPKCareDx)

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ClinicalTrials.gov Identifier: NCT04855422
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : July 22, 2022
Sponsor:
Collaborator:
CareDx
Information provided by (Responsible Party):
Montefiore Medical Center

Brief Summary:

This is a non-randomized, non-interventional, prospective pilot cohort study to monitor SPK patients post-transplant to determine if non-invasive measures using dd-cfDNA (Allosure) and AlloMap can assess an array of immune panels to predict and confirm the development of allograft injury and rejection in either organ.

Aims of the study

  1. To develop and validate AlloSure and AlloMap in SPK transplant recipients with stable allograft function and in diagnosis of acute TCMR and ABMR in either organ
  2. To assess the ability of AlloSure and AlloMap to determine early discordant rejection in SPK recipients
  3. To investigate AlloSure and AlloMap in SPK transplant recipients with diagnosis of BKV viremia

Condition or disease Intervention/treatment
Transplant; Complication, Rejection Diagnostic Test: Allosure Diagnostic Test: AlloMap

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients.
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : December 13, 2022
Estimated Study Completion Date : June 13, 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Stable SPK recipients without rejection and/or BKV viremia
All SPK transplant recipients are monitored for routine labs twice a week first month, weekly at 2nd and 3rd month, every 2 weeks between 3-6 months, once a month between 6-12 months and then once every 2 months.
Diagnostic Test: Allosure
AlloSure Analysis For the AlloSure test, 10-20 mL of blood will be obtained in Streck Cell-Free DNA BCT tubes and shipped to CareDx, Inc. (Brisbane, CA) at ambient temperature in insulated packaging to minimize temperature fluctuation. The AlloSure test will be performed at the CareDx CLIA/CAP-accredited clinical laboratory. Samples will be tested, and results provided within 3 days of blood draw

Diagnostic Test: AlloMap
AlloMap Kidney is intended to aid in the identification of SPK transplant recipients who have a low probability of rejection at the time in testing in conjunction with standard clinical assessment. For the AlloMap-Kidney test, approximately two tubes of blood will be obtained in PAXgene Blood RNA tubes and shipped to CareDx, Inc. (Brisbane, CA), where it will be tested.

Acute T-Cell Mediated Rejection (TCMR )
Kidney and pancreas transplant biopsies will be solely for clinically indicated for increased creatinine, amylase, lipase, blood sugar levels of more than 20% of the baseline, increased spot urine protein/creatinine ratio more than 1 gram/day, and development of donor-specific anti-HLA antibodies.
Diagnostic Test: Allosure
AlloSure Analysis For the AlloSure test, 10-20 mL of blood will be obtained in Streck Cell-Free DNA BCT tubes and shipped to CareDx, Inc. (Brisbane, CA) at ambient temperature in insulated packaging to minimize temperature fluctuation. The AlloSure test will be performed at the CareDx CLIA/CAP-accredited clinical laboratory. Samples will be tested, and results provided within 3 days of blood draw

Diagnostic Test: AlloMap
AlloMap Kidney is intended to aid in the identification of SPK transplant recipients who have a low probability of rejection at the time in testing in conjunction with standard clinical assessment. For the AlloMap-Kidney test, approximately two tubes of blood will be obtained in PAXgene Blood RNA tubes and shipped to CareDx, Inc. (Brisbane, CA), where it will be tested.

Antibody Medicated Rejection (ABMR)
Kidney and pancreas transplant biopsies will be solely for clinically indicated for increased creatinine, amylase, lipase, blood sugar levels of more than 20% of the baseline, increased spot urine protein/creatinine ratio more than 1 gram/day, and development of donor-specific anti-HLA antibodies.
Diagnostic Test: Allosure
AlloSure Analysis For the AlloSure test, 10-20 mL of blood will be obtained in Streck Cell-Free DNA BCT tubes and shipped to CareDx, Inc. (Brisbane, CA) at ambient temperature in insulated packaging to minimize temperature fluctuation. The AlloSure test will be performed at the CareDx CLIA/CAP-accredited clinical laboratory. Samples will be tested, and results provided within 3 days of blood draw

Diagnostic Test: AlloMap
AlloMap Kidney is intended to aid in the identification of SPK transplant recipients who have a low probability of rejection at the time in testing in conjunction with standard clinical assessment. For the AlloMap-Kidney test, approximately two tubes of blood will be obtained in PAXgene Blood RNA tubes and shipped to CareDx, Inc. (Brisbane, CA), where it will be tested.

BKV viremia
All patients will be monitored for BKV viremia monthly after transplantation up to 6 months and at 9, 12 and 24 months. Luminex SAB will be monitored at 1, 3, 12 and 24 months. Spot urine protein and creatinine and HbA1c will be monitored every 3 months after transplantation
Diagnostic Test: Allosure
AlloSure Analysis For the AlloSure test, 10-20 mL of blood will be obtained in Streck Cell-Free DNA BCT tubes and shipped to CareDx, Inc. (Brisbane, CA) at ambient temperature in insulated packaging to minimize temperature fluctuation. The AlloSure test will be performed at the CareDx CLIA/CAP-accredited clinical laboratory. Samples will be tested, and results provided within 3 days of blood draw

Diagnostic Test: AlloMap
AlloMap Kidney is intended to aid in the identification of SPK transplant recipients who have a low probability of rejection at the time in testing in conjunction with standard clinical assessment. For the AlloMap-Kidney test, approximately two tubes of blood will be obtained in PAXgene Blood RNA tubes and shipped to CareDx, Inc. (Brisbane, CA), where it will be tested.

Follow-up of subjects with acute TCMR, ABMR and BKV viremia after treatment
BKV viremia, Luminex SAB, spot urine protein and creatinine is studied at the time clinically indicated biopsy and/o worsening kidney function and proteinuria.
Diagnostic Test: Allosure
AlloSure Analysis For the AlloSure test, 10-20 mL of blood will be obtained in Streck Cell-Free DNA BCT tubes and shipped to CareDx, Inc. (Brisbane, CA) at ambient temperature in insulated packaging to minimize temperature fluctuation. The AlloSure test will be performed at the CareDx CLIA/CAP-accredited clinical laboratory. Samples will be tested, and results provided within 3 days of blood draw

Diagnostic Test: AlloMap
AlloMap Kidney is intended to aid in the identification of SPK transplant recipients who have a low probability of rejection at the time in testing in conjunction with standard clinical assessment. For the AlloMap-Kidney test, approximately two tubes of blood will be obtained in PAXgene Blood RNA tubes and shipped to CareDx, Inc. (Brisbane, CA), where it will be tested.




Primary Outcome Measures :
  1. Establishing benchmarks for AlloSure and AlloMap in SPK transplant recipients with stable allograft function [ Time Frame: 3, 6, 9, and 12 months after enrolment ]
    Allosure score (%) and AlloMap test score (range 0-20) in stable kidney and pancreas transplant recipients


Secondary Outcome Measures :
  1. To develop and validate AlloSure and AlloMap in SPK transplant recipients with diagnosis of acute TCMR and ABMR in either organ [ Time Frame: 3, 6, 9, and 12 months after enrolment or at the time of clinically indicated kidney and/or pancreas biopsies and 2, 4, and 6 weeks after biopsy ]
    Allosure score (%) and AlloMap test score (range 0-20) in kidney and pancreas transplant recipients with rejection (TCMR or ABMR)


Other Outcome Measures:
  1. AlloSure and AlloMap assessment in SPK transplant recipients with diagnosis of BKV viremia [ Time Frame: 3, 6, 9, and 12 months after enrolment and at the time of BKV viremia and 2, 4 and 6 weeks after viremia ]
    Allosure score (%) and AlloMap test score (range 0-20) in kidney and pancreas transplant recipients with BKV viremia



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
Sampling Method:   Probability Sample
Study Population
SPK transplant recipients will be enrolled at the time of transplantation or anytime within 3 years after transplantation starting at least 1 month after transplantation. Patients will have blood samples drawn at the time enrollment and at 3, 6, 9, and 12 months after enrollment and at the time of clinically indicated kidney and/or pancreas transplant biopsy. If the patients had biopsy proven acute or chronic rejection, Allosure and Allomap test will be repeated at 2, 4, and 6 weeks after the diagnosis. For patients who developed BKV viremia, Allosure and Allomap test will be tested at the time of BKV viremia and will be repeated at 2, 4, and 6 weeks after BKV viremia.
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • SKP transplant recipients between 1 month and 3 years after transplantation

Exclusion Criteria:

  • Previous history of solid organ transplantation
  • Pregnancy

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): NCT04855422


Contacts
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Contact: Enver Akalin, MD 877.287.3536 eakalin@montefiore.org
Contact: Maria Ajaimy, MD (718) 920-4321 majaimy@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Enver Akalin, MD    877-287-3536    eakalin@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
CareDx
Investigators
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Principal Investigator: Enver Akalin, MD Montefiore Medical Center
Additional Information:
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT04855422    
Other Study ID Numbers: 2021-12823
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
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