Blood Biomarkers in Pediatric Kidney Transplant Recipients
Recruiting
- Conditions
- Rejection of Kidney Allograft
- Registration Number
- NCT05477082
- Lead Sponsor
- University of Minnesota
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States