Rejection of Kidney Allograft
Conditions
Keywords
acute rejection, kidney transplant, pediatric, biomarker, cell free DNA
Brief summary
The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.
Interventions
OTHERObservational group
Includes blood draws and data collection only
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Kidney transplant recipients * Participants undergoing a for-cause kidney biopsy to rule out graft rejection * Ages 21 years and less
Exclusion criteria
* Participants who have opted out of research * Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read. * Participants, 18 years and older, who are illiterate and cannot read. * Participants, less than 18 years of age, whose parents or legal guardians do not speak English. * Participants, 18 years and older, who do not speak English * Participants who are pregnant as confirmed by medical records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biopsy-proven acute rejection | 7 days from baseline | Yes or No assessment |
| Clinical resolution of rejection | 8 weeks from baseline | Yes or No assessment; defined as improvement in serum creatinine to a value that is within 25% of baseline serum creatinine |
Countries
United States
Outcome results
None listed