Assessment of Donor Derived Cell-free DNA in Combined Kidney-pancreas Recipients

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
United States
Missouri
Washington University
Recruiting
Saint Louis
Contact Information
Primary
Rowena Delos Santos
delossantos@wustl.edu
314-362-8351
Backup
Massini Merzkani
massini@wustl.edu
314-362-8351
Time Frame
Start Date: February 26, 2021
Estimated Completion Date: December 31, 2025
Participants
Target number of participants: 50
Treatments
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.
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.
Authors
Andrew Malone, Rowena Delos Santos
Sponsors
Collaborators: University of Texas, CareDx
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov

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