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Allosure in Simultaneous Pancreas Kidney Transplant

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ClinicalTrials.gov Identifier: NCT04777617
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : April 6, 2021
Sponsor:
Collaborators:
CareDx
University of Texas
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
This study will observe donor derived cell free DNA percentages (via the Allosure test) in combined kidney-pancreas transplant recipients to establish both stable and dysfunctional Allosure assay levels

Condition or disease Intervention/treatment
Kidney Pancreas Transplant Other: DD-cfDNA

Detailed Description:

Simultaneous kidney-pancreas transplantation is the optimal treatment for select patients with type 1 diabetes and kidney failure. Limited biomarkers are utilized to monitor the health of the allografts. For kidney transplantation serum creatinine remains the most commonly monitored biomarker; for the pancreas allograft blood glucose and serum amylase and lipase are measured. However, these biomarkers are imprecise and non-specific for rejection.

In kidney transplantation cell free donor derived DNA at of value of >1% has emerged as an effective immune monitoring tool as a marker for renal allograft rejection and injury. Thus far, a discriminatory donor derived cell free DNA value for a stable and rejecting allografts has not been established for recipients of combined kidney-pancreas transplants.

Study aim will be to help establish a normal range of donor derived cell free DNA in stable kidney-pancreas graft function in combined kidney pancreas transplant recipients while determining changes in cell free DNA in kidney-pancreas recipients with biopsy proven allograft rejection.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Donor Derived Cell-free DNA in Combined Kidney-pancreas Recipients
Actual Study Start Date : February 26, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
WU/Barnes cohort
SPK patients in this group will be recruited from WU/Barnes Transplant center. A total of 25 from this cohort will be recruited and asked to provide a blood sample to test for donor derived cell free DNA 3 times over the course of the first year of transplant. In addition, if any biopsies or rejections occur, additional samples will be requested at the time of biopsy and for an additional two follow-ups at least one month apart.
 Other: DD-cfDNA
We are obtaining samples for donor derived cell free DNA in an observational manner. There is no intervention in this study
UT Southwestern cohort
SPK patients in this group will be recruited from WU/Barnes Transplant center. A total of 25 from this cohort will be recruited and asked to provide a blood sample to test for donor derived cell free DNA 3 times over the course of the first year of transplant. In addition, if any biopsies or rejections occur, additional samples will be requested at the time of biopsy and for an additional two follow-ups at least one month apart.
 Other: DD-cfDNA
We are obtaining samples for donor derived cell free DNA in an observational manner. There is no intervention in this study


Outcome Measures
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Primary Outcome Measures :
  1. DD-cfDNA level [ Time Frame: 1 year ]
    determine level of donor derived cell free DNA from SPK patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This population will be SPK patients with stable Cr, lipase and amylase for at least 2 months post transplant and enrolled within the first year after transplant
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Kidney-pancreas transplant recipients
  • Patient must have stable creatine, lipase, amylase for at least a two month span after transplant OR patient must receive a biopsy within one year post transplant

Exclusion Criteria:

  • Presence of non-renal or pancreas transplanted organ
  • Patient is not enrolled within 1 year after transplant
Contacts and Locations
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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): NCT04777617


Contacts
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Contact: Rowena Delos Santos 314-362-8351 delossantos@wustl.edu
Contact: Devin Wall 314-362-4109 devinwall@wustl.edu

Locations
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United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Rowena Delos Santos, MD    314-362-8351    delossantos@wustl.edu   
Principal Investigator: Rowena Delos Santos, MD         
Sub-Investigator: Andrew Malone         
Sponsors and Collaborators
Washington University School of Medicine
CareDx
University of Texas
Investigators
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Principal Investigator: Rowena Delos Santos, MD Washington University in Saint Louis School of Medicine
More Information
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Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04777617    
Other Study ID Numbers: 202011048
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Washington University School of Medicine:
Kidney pancreas transplant
Deceased donor cell free DNA